MedicalResearch.comExclusive Interviews with Medical Research and

Health Care Researchers from Major and Specialty Medical Research Journals and Meetings

Editor: Marie Benz, MD info@medicalresearch.com

July 13 2014

For Informational Purposes Only: Not for Specific Medical Advice.

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Study Finds No Link Between HPV Vaccine and Blood ClotsMedicalResearch.com Interview with:Nikolai Madrid SchellerDepartment of Epidemiology ResearchStatens Serum Institut, Copenhagen

• Medical Research: What are the main findings of the study?• Answer: In a large and comprehensive study of more than 1.5 million women including more

than 500,000 HPV vaccinated there was no association between HPV vaccination and blood clots.

Medical Research: What should clinicians and patients take away from your report?• Answer: The HPV vaccines are now included in immunization programs around the world and

emerging safety issues need to be addressed in thorough and well-designed studies to inform policymakers, caregivers, and the public. Our study adds to the body of data that support a favorable overall safety profile of the qHPV vaccine and expands this knowledge by providing comprehensive analyses of the risk of VTE after qHPV vaccination.

• Medical Research: What recommendations do you have for future research as a result of this study?

• Answer: It is essential that other severe adverse events reported in temporal association with HPV-vaccination are investigated in detail in controlled and well-powered studies to either confirm or refute an association with the vaccine in question, as earlier experiences have demonstrated that such safety concerns might compromise vaccine acceptance and uptake.

• Citation:• Scheller N, Pasternak B, Svanström H, Hviid A. Quadrivalent Human Papillomavirus Vaccine a

nd the Risk of Venous Thromboembolism. JAMA. 2014;312(2):187-188. doi:10.1001/jama.2014.2198.

•

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Childhood Obesity: Sibling Influence May Be Greater Than ParentsMedicalResearch:.com Interview with: Mark C. Pachucki, PhDSenior Scientist, Mongan Institute for Health PolicyAffiliated Faculty, MGHfC Division of General Academic Pediatrics

Instructor in Medicine and Pediatrics, Harvard Medical School Boston, MA 02114

• MedicalResearch: What are the main findings of the study?• Dr. Pachucki: We found that in in one-child families, having an obese parent made a child

about twice as likely to be obese themselves. However, in two-child families, a child’s obesity status was more strongly related with their sibling than with their parent. Even more interesting, in the case of the younger sibling, the parent’s obesity status was not related with that child’s obesity status at all. These findings matter because family members are primary sources of social influence for children – understanding how health status is correlated within a family gives us a better foothold on possible intervention strategies.

• MedicalResearch: Were any of the findings unexpected?• Dr. Pachucki: We’ve known from prior research that there’s a strong parent-child obesity link,

and separate studies have shown that there’s a strong sibling-sibling obesity correlation as well. Parents model healthy and unhealthy behaviors for their children through their own actions; siblings do this as well. So it wasn’t immediately clear which kind of obesity relationship would be stronger. I went into this with a hunch that given parents’ oversize roles in their kids’ lives, parent-child obesity would be stronger than sibling-sibling obesity, but I was surprised that it was the opposite. What’s also interesting is that if siblings were of the same gender, it made a big difference in their shared obesity status. Having an older brother who is obese makes it more likely that a younger brother will also be obese. For girls, the pattern was the same – having an obese older sister increases the odds that the younger sister will be obese.

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Childhood Obesity: Sibling Influence May Be Greater Than ParentsMedicalResearch:.com Interview with: Mark C. Pachucki, PhDSenior Scientist, Mongan Institute for Health PolicyAffiliated Faculty, MGHfC Division of General Academic Pediatrics

Instructor in Medicine and Pediatrics, Harvard Medical School Boston, MA 02114

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Pachucki: Our health is often more connected with the other people in our lives than we

commonly recognize. Clinicians should continue to pay close attention to the health status and behaviors of other people in a child’s family. For adult patients who have children, our message isn’t that your health doesn’t matter to your child’s health, but that during a child’s development, their siblings may play a greater role in their health behaviors and health outcomes. For child patients, our message is that if they make efforts to eat healthy food and get enough exercise, it can also improve the health of their brother or sister.

• MedicalResearch: What recommendations do you have for future research as a result of this study?

• Dr. Pachucki:: This was a relatively modest study concerned with reported behaviors, and it would be great to replicate it on a larger scale with more detailed information on family members’ measured food intake, physical activity and weight status. We also recognize that obesity is a result of a mix of behavioral, social, and genetic factors, and we could only look at part of the puzzle. Our study was a cross-sectional snapshot at one point in time, and we examined correlations, not causal relationships. Longitudinal data could provide stronger evidence of sibling or parental responsibility for a child’s health. More concrete knowledge in this area would help us use information about relationships to improve family-based obesity interventions.

• Citation:• Within-Family Obesity Associations

Pachucki, Mark C. et al. American Journal of Preventive Medicine

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Hypoxia Associated With Improved Insulin SensitivityMedicalResearch.com Interview with:Eric Ravussin, Ph.D., Boyd Professor Director Nutrition Obesity Research CenterDouglas L. Gordon Chair in Diabetes and Metabolism

Associate Executive Director for Clinical Science Baton Rouge LA

• Medical Research: What is the background of this study?• Dr. Ravussin: It has long been postulated that hypoxia is bad for metabolic health. • Hypoxia of adipose tissue has been thought to cause oxidative stress, resulting in the

recruitment of macrophages with resultant secretion of cytokines and inflammation. However, repeated bouts of hypoxia induced during vigorous exercise results in increased glucose uptake and vascularization of muscle tissue. In addition, living at high altitude is associated with a lower prevalence of impaired fasting glucose and type 2 diabetes compared with living at low altitude.

• Therefore, we asked the question, “What is the balance between the beneficial effects of hypoxia in muscle tissue and ‘bad’ effects in adipose tissue”? We devised a study in eight healthy men of different ethnicities, put into a hypoxic environment for 10 consecutive nights for 10 hours. The subjects slept in a hypoxic tent, using nitrogen dilution.

• Medical Research: What are the main findings of the study?• Dr. Ravussin: The main findings of this study included:• Adipose tissue hypoxia was confirmed;• Subjects lost an average of 1.2 kg;• This study reports for the first time a reduced fasting glucose level and improved whole-body

(skeletal muscle) and hepatic insulin sensitivity after nightly exposure to moderate hypoxia.

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Hypoxia Associated With Improved Insulin SensitivityMedicalResearch.com Interview with:Eric Ravussin, Ph.D., Boyd Professor Director Nutrition Obesity Research CenterDouglas L. Gordon Chair in Diabetes and Metabolism

Associate Executive Director for Clinical Science Baton Rouge LA

• Medical Research: Were any of the findings unexpected?• Dr. Ravussin: Insulin sensitivity increased a surprising 23%, with a significant improvement in the glucose

disposal rate (measured using a hyper-insulinemic euglycemic clamp)• Medical Research: What should clinicians and patients take away from your report?• Dr. Ravussin: Our study suggests that while hypoxia may be bad for adipose tissue, it may not be bad

overall in terms of metabolic health. The impact on appetite in particular is interesting, as it is known that individuals often lose weight when exposed to high altitudes. At this point, we can speculate that occasional hypoxia may be somewhat protective against diabetes.

• Medical Research: What recommendations do you have for future research as a result of this study?Dr. Ravussin:

• First, we have applied for a grant to do a similar study in diabetics, using an oral glucose tolerance test instead of a clamp.

• Second, we would like to examine alternatives to a hypoxic tent, perhaps using a CPAP type mask.• Third, we would like to study whether less frequent hypoxic exposure, perhaps 1-2 nights per week, would

have a beneficial effect on insulin sensitivity and fasting glucose.• Citation:• Ten Nights of Moderate Hypoxia Improves Insulin Sensitivity in Obese Humans • Virgile Lecoultre, Courtney M. Peterson, Jeffrey D. Covington, Philip J. Ebenezer, Elizabeth A. Frost, Jean-Ma

rc Schwarz, and Eric Ravussin

Diabetes Care December 2013 36:12 e197-e198; doi:10.2337/dc13-1350 1935-5548

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Best Way To Avoid Repeat ACL Injury Is To Avoid Cutting ActivitiesMedicalResearch.com Interview with:Christoher C. Kaeding M.D. Judson Wilson Professor, Department of OrthopaedicsExecutive Director, Sports Medicine Center

Head Team Physician, Department of Athletics The Ohio State University

• MedicalResearch: What are the main findings of the study?Dr. Kaeding:

• Younger age and high activity level were predictors off another ACL injury after an ACL Reconstruction.

• Allograft use in younger more active patients Had an increased risk of re-injury.•

MedicalResearch: Were any of the findings unexpected?• Dr. Kaeding: That gender was not a risk factor for re-injury may surprise some people.• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Kaeding: The best WAY TO AVOID ANOTHER ACL INJURY IS TO NOT RETURN TO AGGRESSIVE

CUTTING ACTIVITIES• MedicalResearch: What recommendations do you have for future research as a result of this

study?• Dr. Kaeding: We need do more research into Allograft use in ACL surgery..• Citation: Abstract Presented at the AOSSM 2014 Annual Meeting abstract discussing:• Paper 24: Risk Factors and Predictors of Subsequent ACL Injury after ACL

Reconstruction: Prospective Analysis of 2801 Primary ACL ReconstructionsChristopher C. Kaeding MD, Angela Pedroza MPH, Emily Reinke PhD, Laura J. Huston MS, on behalf of MOON Group, The Ohio State University, Columbus, OH

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Kidney Stone Risk Rises With the TemperatureMedicalResearch.com Interview with:Gregory Tasian, MD, MSc, MSCEAttending UrologistThe Children’s Hospital of Philadelphia

• Medical Research: What are the main findings of the study?• Dr. Tasian: The risk of developing kidney stones increased during the study period in all the cities except Los Angeles

when mean daily temperatures rose above 50°F (10°C). Mean daily temperatures reaching 86°F (30°C) were associated with risk increases of 38% in Atlanta, 37% in Chicago, 36% in Dallas, and 47% in Philadelphia compared with 50°F (10°C). Kidney stone risk peaked within 3-5 days of exposure to high temperatures but then decreased within 7 to 10 days afterward.

• Medical Research: Were any of the findings unexpected?• Dr. Tasian: The risk of kidney stone presentation also increased at low temperatures in Atlanta, Chicago, and

Philadelphia. One possible explanation is that patients were spending more time inside and thus have a risk of stones associated with warmer indoor temperatures.

• Medical Research: What should clinicians and patients take away from your report?• Dr. Tasian: For patients who are susceptible to stone formation, the risk of seeking care for kidney stones increases

as daily temperatures risk.• Medical Research: What recommendations do you have for future research as a result of this study? • Dr. Tasian: These findings need to be validated in other populations, including the un or underinsured. Additionally,

further studies to determine whether, race, age, or sex modifies the effect of temperature will help elucidate particular groups of patients particularly vulnerable to heat-mediated nephrolithiasis. Ultimately, it is necessary to develop strategies to increase water intake, which mitigates the effect of dehydration on heat-mediated stone risk, among patients who have a history of kidney stones.Citation:

• Daily Mean Temperature and Clinical Kidney Stone Presentation in Five U.S. Metropolitan Areas: A Time-Series AnalysisGregory E. Tasian,1,2,3 Jose E. Pulido,2 Antonio Gasparrini,4 Christopher S. Saigal,5,6 Benjamin P. Horton,7,8

J. Richard Landis,9 Rodger Madison,6 and Ron Keren3,9,10 for the Urologic Diseases in America ProjectEnviron Health Perspect; DOI:10.1289/ehp.1307703

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Psychiatric Medications Linked To High Number of ER VisitsMedicalResearch.com interview with:Lee M. Hampton, MD, MSc: Division of Healthcare Quality PromotionCenters for Disease Control and Prevention Atlanta, Georgia

• Medical Research: What are the main findings of the study?• Dr. Hampton: The study, which used CDC’s national outpatient adverse drug event surveillance

system (NEISS-CADES), found that there are almost 90,000 estimated annual emergency department visits by adults for adverse drug events from therapeutic use of antipsychotics, antidepressants, sedatives and anxiolytics, lithium salts or stimulants between 2009 and 2011. Almost one in five of those emergency department visits (19.3%) resulted in hospitalization. Sedatives and anxiolytics, antidepressants, and antipsychotics each caused 20,000 to 30,000 emergency department visits annually. However, relative to how often each of these types of medications was prescribed at outpatient visits, antipsychotics and lithium salts were more likely to cause emergency department visits for adverse drug events than were sedatives, stimulants, and antidepressants. Antipsychotics caused 3.3 times more emergency department visits for adverse drug events than sedatives, 4.0 times more emergency department visits than stimulants, and 4.9 times more emergency department visits than antidepressants relative to their outpatient use.

• Out of the 83 specific drugs the study looked at, ten drugs were implicated in nearly 60% of the emergency department visits for ADEs from therapeutic use of antipsychotics, antidepressants, sedatives and anxiolytics, lithium salts or stimulants. Zolpidem was implicated in nearly 12% of all such emergency department visits and 21% of such emergency department visits involving adults aged 65 years or older, more than any other antipsychotic, antidepressant, sedative or anxiolytic, lithium salt or stimulant.

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Psychiatric Medications Linked To High Number of ER VisitsMedicalResearch.com interview with:Lee M. Hampton, MD, MSc: Division of Healthcare Quality PromotionCenters for Disease Control and Prevention Atlanta, Georgia

• Medical Research: Were any of the findings unexpected?• Dr. Hampton: We were surprised that almost half (49.4%) of adult emergency department

visits for adverse events from the psychiatric drugs we looked at involved patients who were 19-44 years old. That means patients who were 19-44 years old had almost as many emergency department visits for ADEs from therapeutic use of antipsychotics, antidepressants, sedatives and anxiolytics, lithium salts or stimulants as did adults who were 45 years old or older. Even when you take the different age group’s use of these drugs into account, the adults who were 19 to 44 years old had more ED visits for antipsychotic, sedative and anxiolytic, and antidepressant adverse events than did adults 45 to 64 years old or adults who were 65 years old or older.

• We are not certain why that was the case, but younger adults may be more likely to visit an ED if they have a problem and ED doctors may be more likely to think a younger patient’s problem was due a drug, in part because a younger patient usually has fewer chronic medical conditions that could also have caused his or her problem. Nevertheless, the large number of ED visits for adverse events from psychiatric drugs among young people shows that adverse events from these drugs are a problem for all age groups, not just the elderly.

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Psychiatric Medications Linked To High Number of ER VisitsMedicalResearch.com interview with:Lee M. Hampton, MD, MSc: Division of Healthcare Quality PromotionCenters for Disease Control and Prevention Atlanta, Georgia

• Medical Research: What should clinicians and patients take away from your report?• Dr. Hampton: Last year, the leaders of the American Psychiatric Association, psychiatrists’

professional organization, urged doctors to use antipsychotics cautiously and only after exploring the feasibility of using alternate treatments. Our report reinforces that it is important for doctors and patients to heed the warning from the American Psychiatric Association to be cautious in their use of antipsychotics.

• Doctors and patients should also be cautious in using zolpidem and other sedatives, particularly because there are many treatment options for insomnia, the condition which zolpidem is intended to treat.

• Medical Research: What recommendations do you have for future research as a result of this study?

• Dr. Hampton: There have been many developments over the last few years that could influence how many adverse events from psychiatric medication use occur, ranging from the warnings from the American Psychiatric Association to revisions to the Diagnostic and Statistical Manual used to make psychiatric diagnoses to some of these medications going off patent. It will be useful to track the number of emergency department visits for adverse events from psychiatric drugs changes over time in response to those developments.

• Citation:• Hampton LM, Daubresse M, Chang H, Alexander G, Budnitz DS. Emergency Department Visits by

Adults for Psychiatric Medication Adverse Events. JAMA Psychiatry. Published online July 09, 2014. doi:10.1001/jamapsychiatry.2014.436.

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End Stage Kidney Disease: Does Peritoneal Dialysis Offer A Survival Advantage?MedicalResearch.com Interview with:Victoria A. Kumar, M.D. Internal Medicine/NephrologyDivision of Nephrology Department of Internal Medicine

Southern California Permanente Medical Group Los Angeles, California, USA

• Medical Research: What are the main findings of the study?• Dr. Kumar: There was over a 2 fold increase in patient survival in incident peritoneal dialysis

patients in the first year on dialysis compared to propensity matched incident hemodialysis patients. We excluded any patients who utilized a central dialysis catheter at any point during the first 90 days on hemodialysis in an effort to reduce the mortality bias associated with hemodialysis patients who start with a catheter. All hemodialysis patients had pre-dialysis care by a nephrologist prior to starting dialysis.

• The 2+ fold increase in survival among peritoneal dialysis patients resulted in a 2-3 year cumulative survival advantage for peritoneal dialysis patients, using both intent to treat and as-treated analyses.

Medical Research: Were any of the findings unexpected?• Dr. Kumar: Given that a couple of recent reports had attributed the initial 1-2 year survival

advantage seen in PD patients in several large studies to the early use of central venous catheters among matched hemodialysis patients, our findings were surprising. Other authors have attributed the initial 1-2 year survival advantage seen in other studies to lack of pre-dialysis care, but all of our study patients were managed by a nephrologist prior to starting PD/HD.

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End Stage Kidney Disease: Does Peritoneal Dialysis Offer A Survival Advantage?MedicalResearch.com Interview with:Victoria A. Kumar, M.D. Internal Medicine/NephrologyDivision of Nephrology Department of Internal Medicine

Southern California Permanente Medical Group Los Angeles, California, USA

• Medical Research: What are the main findings of the study?• Dr. Kumar: There was over a 2 fold increase in patient survival in incident peritoneal dialysis

patients in the first year on dialysis compared to propensity matched incident hemodialysis patients. We excluded any patients who utilized a central dialysis catheter at any point during the first 90 days on hemodialysis in an effort to reduce the mortality bias associated with hemodialysis patients who start with a catheter. All hemodialysis patients had pre-dialysis care by a nephrologist prior to starting dialysis.

• The 2+ fold increase in survival among peritoneal dialysis patients resulted in a 2-3 year cumulative survival advantage for peritoneal dialysis patients, using both intent to treat and as-treated analyses.

Medical Research: Were any of the findings unexpected?• Dr. Kumar: Given that a couple of recent reports had attributed the initial 1-2 year survival

advantage seen in PD patients in several large studies to the early use of central venous catheters among matched hemodialysis patients, our findings were surprising. Other authors have attributed the initial 1-2 year survival advantage seen in other studies to lack of pre-dialysis care, but all of our study patients were managed by a nephrologist prior to starting PD/HD.

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End Stage Kidney Disease: Does Peritoneal Dialysis Offer A Survival Advantage?MedicalResearch.com Interview with:Victoria A. Kumar, M.D. Internal Medicine/NephrologyDivision of Nephrology Department of Internal Medicine

Southern California Permanente Medical Group Los Angeles, California, USA

• Medical Research: What should clinicians and patients take away from your report?• Dr. Kumar: The survival advantage afforded by peritoneal dialysis in the first couple years on

dialysis should be emphasized when patients are in the process of choosing a dialysis modality.

• Medical Research: What recommendations do you have for future research as a result of this study?

• Dr. Kumar: RCT comparing peritoneal dialysis to hemodialysis is probably not feasible. Future studies might address the issue of baseline residual renal function and changes in residual renal function over time when comparing survival among well matched PD/HD patients.

• Citation:Survival of propensity matched incident peritoneal and hemodialysis patients in a United States health care system

Victoria A Kumar1, Margo A Sidell2, Jason P Jones2 and Edward F Vonesh3Kidney International advance online publication 2 July 2014; doi: 10.1038/ki.2014.224

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Reducing Overuse of Cardiac Biomarkers Generates Substantial Health Care SavingsMedicalResearch.com Interview with:Jeff Trost, MDAssistant Professor of MedicineJohns Hopkins Medicine

• Dr. Trost: In our study, we reported the use of two relatively simple tactics to significantly reduce the number of unnecessary blood tests to assess symptoms of heart attack and chest pain and to achieve a large decrease in patient charges.

• Specifically, we• 1) Provided information and education to physicians about proven testing guidelines and• 2) Made changes to the computerized provider order entry system at the medical center, part of the Johns Hopkins Health

System. The guidelines call for more limited use of blood tests for so-called cardiac biomarkers. A year after implementation, our intervention led to an estimated $1.25 million reduction in laboratory charges.

•Medical Research: Were any of the findings unexpected?

• Dr. Trost: No, based on a small sample of our pre-intervention utilization pattern, we estimated that there was a significant amount of “overuse” of this testing and that reducing the “overuse” would lead to a significant reduction in laboratory charges.

• Medical Research: What should clinicians and patients take away from your report?• Dr. Trost: We believe that clinicians should consider eliminating the use of CK-MB if troponin is available at their institutions,

because CK-MB adds no incremental value over troponin in the evaluation and diagnosis of patients with chest pain. CK-MB is an example of a low-value (and some would argue, zero-value) test for patients.

• We would also add that clinicians need to consider appropriate use of serial troponin values – typically, it only takes 2 or 3 values at most to make or exclude a diagnosis of acute coronary syndrome.

• Medical Research: What recommendations do you have for future research as a result of this study?• Dr. Trost: Future research could center on applying our intervention – provider education and EMR changes – to the

appropriate ordering practice of other tests that are deemed to have little or no value in clinical practice.• Citation:• Reducing Excess Cardiac Biomarker Testing at an Academic Medical Center

Marc R. Larochelle MD,Amy M. Knight MD,Hardin Pantle MD, Stefan Riedel MD, PhD, Jeffrey C. Trost MDJournal of General Internal Medicine June 2014

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Smoking Plus Mental Illness Leads To Substantial Economic BurdenMedicalResearch.com Interview with: Ms Qi Wu:Mental Health and Addiction Research Group, Department of Health SciencesUniversity of York, HeslingtonYork UK

• Medical Research: What are the main findings of the study?• Ms Qi Wu: At any time in the UK about one in six adults has a mental health problem, the prevalence

of smoking in this group is over 33%, which is around 50% higher than in the general population. It is estimated that 3 million adults with mental disorders were smokers in 2009-10. Meanwhile, people with mental health disorders are also more likely to smoke heavily, this group accounts for as much as 42% of the total national tobacco consumption. In this study, we calculated the avoidable economic burden of smoking in people with mental disorders.

• The main finding was that people with mental disorders who smoke cost the UK economy £2.34 billion a year. The total costs are more or less equally divided among losses sustained from premature death, lost productivity, and healthcare costs to treat smoking related diseases such as lung cancer, cardiovascular disease and chronic obstructive pulmonary disease (COPD) in this group. An estimated £719 million (31% of the total cost) was spent on treating diseases caused by smoking. Productivity losses due to smoking-related diseases were about £823 million (35%) for work- related absenteeism and £797 million (34%) was associated with premature mortality.

Medical Research: What should clinicians and patients take away from your report?• Ms Qi Wu: Smokers with mental disorders using primary and secondary care services should be

identified and provided with specialist smoking cessation support. Professionals working with or caring for people with mental disorders should be trained in awareness of smoking as a major health issue, to deliver brief cessation advice, to provide or arrange further support to those who want to quit. Smoke-free policy is crucial to promoting smoking cessation in mental health settings.

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Smoking Plus Mental Illness Leads To Substantial Economic BurdenMedicalResearch.com Interview with: Ms Qi Wu:Mental Health and Addiction Research Group, Department of Health SciencesUniversity of York, HeslingtonYork UK

• Medical Research: What recommendations do you have for future research as a result of this study?

• Ms Qi Wu: The result of this study showed that smoking in people with mental disorders imposes a significant economic burden and therefore that development and implementation of smoking cessation interventions in this group is a particularly high priority. Research funding agencies should consider encouraging and investing in research to address this major cause of ill-health. Further research is needed to develop tailored smoking cessation support to increase cessation in people with mental disorders. For those smokers who can’t quit smoking, it is important to integrate harm reduction and temporary abstinence strategies into mental healthcare delivery to reduce the harm of smoking.

• Citation:• Economic cost of smoking in people with mental disorders in the UKQi Wu,Lisa Szatkowski,Jo

hn Britton, Steve Parrott• Tob Control tobaccocontrol-2013-051464Published Online First: 9 July 2014 doi:10.1136/tobac

cocontrol-2013-051464

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Childhood Tuberculosis Likely Under-diagnosed and Under-reportedMedicalResearch.com Interview with:Pete Dodd (BA, BSc, MMath, PhD)Research associate in health economic modellingHealth Economics and Decision Science ScHARR Regent

Court Sheffield

• Medical Research: What are the main findings of the study?• Dr. Dodd: We found that over 650,000 children under the age of 15 developed tuberculosis in the 22

highest burden countries in 2010, with around 7.6 million becoming infected with the bacillus and more than 50 million harboring latent infection.Our work points to a much larger gap between notifications and incidence in children compared to adults.

Medical Research: Were any of the findings unexpected?• Dr. Dodd: It is known that tuberculosis in children is often under-diagnosed and under-reported.

However, traditional burden estimates start from notification figures, and it is challenging to determine how much to scale up these figures in children to arrive at incidence. Our approach used mathematical modelling to start from the estimated tuberculosis burden in adults, which introduces more uncertainty, but circumvents this problem.

• Medical Research: What should clinicians and patients take away from your report?• Dr. Dodd: Tuberculosis in children is a major health problem globally, and wider use of isoniazid

preventive therapy in eligible children exposed to tuberculosis should be facilitated. Improving diagnosis and reporting of tuberculosis in children should be on the public health agenda.

• Citation:• Burden of childhood tuberculosis in 22 high-burden countries: a mathematical modelling study

The Lancet Global Health – 9 July 2014 DOI: 10.1016/S2214-109X(14)70245-1

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Regular Use of Some NSAIDs May Increase Adverse Cardiovascular Events.MedicalResearch.com Interview with:Anthony Bavry, MD MPHInterventional Cardiology, North Florida/South Georgia Veterans Health System

Associate Professor of Medicine, University of Florida Gainesville, FL 32610

• Medical Research: What are the main findings of the study? Dr. Bavry:1) Among post-menopausal women, the regular use of NSAIDs was associated with an increased risk of cardiovascular death, myocardial infarction, or stroke.2) Cardiovascular risk was observed among users of celecoxib, naproxen, but not ibuprofen.

Medical Research: Were any of the findings unexpected?• Dr. Bavry: The finding of naproxen being associated with risk was consistent with our initial study

hypothesis. This finding may be unexpected to many readers. We hypothesized that naproxen would be associated with harm because this agent is a non-selective NSAID with more cox-2 than cox-1 inhibition.

• Medical Research: What should clinicians and patients take away from your report? • Dr. Bavry: Regular use of NSAIDs (celecoxib and naproxen) can increase adverse cardiovascular events.• Medical Research: What recommendations do you have for future research as a result of this study?• Dr. Bavry: Future studies are needed to define risks of NSAIDs in men and the role of dose and

duration in determining adverse cardiovascular risk of these agents.• Citation:

Nonsteroidal Anti-Inflammatory Drugs and Cardiovascular Outcomes in Women: Results From the Women’s Health Initiative Circ Cardiovasc Qual Outcomes. 2014;CIRCOUTCOMES.113.000800published online before print July 8 2014

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Pancreatic Cancer: Combination Chemotherapy Increases SurvivalMedicalResearch.com Interview with:Andrea Wang-GillamMD, PhDAssistant Professor, Department of MedicineOncology Division, Medical Oncology Section Washington

University School of Medicine in St. Louis

• Medical Research: What are the main findings of the study?• Dr. Wang-Gillam: This is a global randomized phase III trial of MM398 plus 5FU/LV vs. MM398 vs.

5FU/LV in patients with metastatic pancreatic cancer who had received prior gemcitabine-based therapy. The primary endpoint was overall survival (OS). The secondary endpoints included progression-free survival (PFS), response rate (RR), biochemical response and safety. The trial achieved its primary endpoint. The median overall survival was statistically longer with the combination of MM398 plus 5FU/LV compared with 5FU/LV alone (6.1 months vs 4.2 months; HR of 0.67; p=0.0122). A superior progression-free survival was also seen in the MM398 plus 5FU/LV group compared with the 5FU/LV alone group (3.1 months vs 1.5 months; HR of 0.56; p=0.0001). A higher response rate was observed in the combination regimen compared with the 5FU/LV group (16% vs 1%). There were no differences in overall survival or PFS between the MM 398 monotherapy and 5FU/LV groups.

Medical Research: Were any of the findings unexpected?• Dr. Wang-Gillam: Some unexpected findings appeared in the MM398 monotherapy arm.• First, in terms of efficacy, although MM398 monotherapy resulted in a higher RR and biochemical

response compared with 5FU/LV, there was no difference in OS and PFS between MM 398 monotherapy and 5FU/LV treatment.

• Second, regarding toxicity, the study reported a higher incidence of grade 3 or above adverse events in the GI tract such as diarrhea, vomiting and hypokalemia in the MM398 monotherapy group compared with the MM398 plus 5FU/LV group.

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Pancreatic Cancer: Combination Chemotherapy Increases SurvivalMedicalResearch.com Interview with:Andrea Wang-GillamMD, PhDAssistant Professor, Department of MedicineOncology Division, Medical Oncology Section Washington

University School of Medicine in St. Louis

• Medical Research: What should clinicians and patients take away from your report?• Dr. Wang-Gillam: There are a couple of important take home messages from this study.• First, the study has met its primary endpoint demonstrating that the combination of MM398 plus 5FU/LV resulted in

a superior overall survival compared with 5FU/LV alone.• The combination could be another treatment option for metastatic pancreatic cancer patients who have previously

received gemcitabine-based regimens. Second, the toxicities of the combination of MM398 plus 5FU/LV were acceptable and manageable.

• Third, the study accrued 417 patients globally in less than 2 years, reflecting a desperate need for novel therapy in this patient population.

• Medical Research: What recommendations do you have for future research as a result of this study?• Dr. Wang-Gillam: MM398 is a novel delivery system for irinotecan. Because of the delivery system, MM398 can

linger in circulation longer compared with the conventional irinotecan. Furthermore, this nanoliposomal delivery system allows a higher uptake of the drug at the tumor site and possible subsequent local conversion to its active metabolite SN-38. In light of these favourable features, I anticipate MM398 will be studied for the treatment of many different kinds of tumors, especially those for which conventional irinotecan has already demonstrated its clinical efficacy. As a GI oncologist, I would like see large clinical studies using regimens containing MM398 in several GI cancers including colorectal cancer and gastric cancer.

• Last but not least, in light of the efficacy of FOLFIRINOX, I personally would advocate for a study investigating MM398 combined with 5FU/LV and oxaliplatin in the front-line setting for locally advanced or metastatic pancreatic cancer.

• Citation: Abstract• MM-398 Added to Standard Treatment Shows Survival Benefit in Mets Pancreatic Cancer Published: June 25, 2014.

By European Society for Medical Oncologyhttp://www.esmo.org

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Premenopausal Breast Cancer: Exemestane Found Superior to Tamoxifen in Estrogen Positive DiseaseMedicalResearch.com Interview with: Dr. Olivia PaganiClinical Director of the Breast Unit of Southern SwitzerlandOspedale San Giovanni, Switzerland

• Medical Research: What are the main findings of the study?• Dr. Pagani: The study showed that the aromatase inhibitor Exemestane is superior to Tamoxifen (both given together

with ovarian function suppression) in preventing breast cancer recurrence in premenopausal women with oestrogen receptor positive early breast cancer.

• Medical Research: Were any of the findings unexpected?• Dr. Pagani: We designed the 2 studies (SOFT and TEXT) to confirm the results achieved with aromatase inhibitors in

menopausal women and in fact the benefit, in terms of disease free survival, is in the same range of that seen in postmenopausal women with aromatase inhibitors.

• Medical Research: What should clinicians and patients take away from your report?• Dr. Pagani: The combination of an aromatase inhibitor (in our study Exemestane) and ovarian function suppression is a

very effective treatment option in this population of patients. In women for whom ovarian function is indicated, Exemestane should be preferred to Tamoxifen. In addition, overall survival at 5 years is excellent in both treatments groups, and also in women who do not receive chemotherapy, which is a very important information for young women with oestrogen receptor positive breast cancer.

• Medical Research: What recommendations do you have for future research as a result of this study?• Dr. Pagaini: The SOFT trial will also answer (by the end of the year) the pending question of the added benefit of

ovarian suppression in patients receiving tamoxifen. All these data will allow to better tailor treatment decisions in our individual patients. We will also deeply analyse our data to see if any patients’ or disease characteristics are associated with better outcome or different toxicity profile.

• Citation:• Adjuvant Exemestane with Ovarian Suppression in Premenopausal Breast Cancer• Olivia Pagani, M.D., Meredith M. Regan, Sc.D., Barbara A. Walley, M.D., Gini F. Fleming, M.D., Marco Colleoni, M.D., Istv

án Láng, M.D., Henry L. Gomez, M.D., Carlo Tondini, M.D., Harold J. Burstein, M.D., Edith A. Perez, M.D., Eva Ciruelos, M.D., Vered Stearns, M.D., Hervé R. Bonnefoi, M.D., Silvana Martino, D.O., Charles E. Geyer, Jr., M.D., Graziella Pinotti, M.D., Fabio Puglisi, M.D., Diana Crivellari, M.D., Thomas Ruhstaller, M.D., Eric P. Winer, M.D., Manuela Rabaglio-Poretti, M.D., Rudolf Maibach, Ph.D., Barbara Ruepp, Pharm.D., Anita Giobbie-Hurder, M.S., Karen N. Price, B.S., Jürg Bernhard, Ph.D., Weixiu Luo, M.S., Karin Ribi, Ph.D., Giuseppe Viale, M.D., Alan S. Coates, M.D., Richard D. Gelber, Ph.D., Aron Goldhirsch, M.D., and Prudence A. Francis, M.D. for the TEXT and SOFT Investigators and the International Breast Cancer Study Group

• N Engl J Med 2014; 371:107-118July 10, 2014DOI: 10.1056/NEJMoa1404037

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ICU Admission For Pulmonary Embolism Varies By HospitalMedicalResearch.com Interview with:Dr. Colin Cooke MD, MSc, MSAssistant Professor, Department of Internal Medicine University of MichiganCenter for Healthcare Outcomes and Policy Ann

Arbor, MI

• Medical Research: What are the main findings of the study?• Dr. Cooke: We determined that when patients who are hospitalized for pulmonary embolism (PE), a

blood clot in the lung, approximately 1 in 5 will be admitted to an intensive care unit (ICU). However, the chances that a patient will go to an ICU is highly dependent upon which hospital they are admitted to. For example, some hospitals admitted only 3% of patients with pulmonary embolism to an ICU while others admitted almost 80%.

• Importantly, the differences in how hospitals use their ICU for patients with pulmonary embolism was not entirely related to the patient’s need for life support measures, the things that the ICU is designed to deliver. For example, the ICU patients in high ICU-use hospitals tended to receive fewer procedures, including mechanical ventilation, arterial catheterization, central lines, and medications to dissolve blood clots. This suggest that high utilizing hospitals are admitting patients to the ICU with weaker indications for ICU admission.

• Medical Research: Were any of the findings unexpected?• Dr. Cooke: We know from prior research that care delivered in an ICU is often quite expensive relative

to the care provided in other areas of the hospital. We expected that hospitals that admitted more of their patients with pulmonary embolism to the ICU would also be the higher cost hospitals. However, this was not the case. In fact, we observed no differences in either the costs for other outcomes, such a patient’s risk of death or their risk for hospital readmission, in hospitals using more ICU care. This may be because hospitals that admit more patients with pulmonary embolism to the ICU are admitting those with fewer needs for ICU therapies, thereby negating some of the excess costs of care in an ICU.

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ICU Admission For Pulmonary Embolism Varies By HospitalMedicalResearch.com Interview with:Dr. Colin Cooke MD, MSc, MSAssistant Professor, Department of Internal Medicine University of MichiganCenter for Healthcare Outcomes and Policy Ann

Arbor, MI

• Medical Research: What should clinicians and patients take away from your report?• Dr. Cooke: Clinicians should recognize that in many patients with pulmonary embolism the

ICU is an appropriate location within the hospital to best care for patients. In particular, those who require life support measures as well as those who are at risk of rapid decompensation certainly benefit from ICU care. However, there are also likely a subset of low risk patients with PE who could effectively be managed in alternative locations. Doing so may free up ICU beds for more acutely ill patients, and ultimately reduce the costs of care for patients with this condition.

• Medical Research: What recommendations do you have for future research as a result of this study?

• Dr. Cooke: The most important next steps will require a better understanding of why ICU admission practice varies so dramatically across hospitals. Because we observed no differences in outcomes in pulmonary embolism patients across hospitals with differing ICU use, this suggests that there may be great opportunities to improve the efficiency in use of the ICU.

• Citation:• Hospital-level variation in intensive care unit admission and critical care procedures for patie

nts hospitalized for pulmonary embolism• Andrew J. Admon, MD, MPH; Christopher W. Seymour, MD, MSc; Hayley B. Gershengorn, MD

; Hannah Wunsch, MD, MSc; Colin R. Cooke, MD, MSc, MS• Chest. 2014. doi:10.1378/chest.14-0059Read the rest of the interview on MedicalResearch.comContent Not Intended as Specific Medical Advice

ICU Admission For Pulmonary Embolism Varies By HospitalMedicalResearch.com Interview with:Dr. Colin Cooke MD, MSc, MSAssistant Professor, Department of Internal Medicine University of MichiganCenter for Healthcare Outcomes and Policy Ann

Arbor, MI

• Medical Research: What are the main findings of the study?• Dr. Cooke: We determined that when patients who are hospitalized for pulmonary embolism (PE), a

blood clot in the lung, approximately 1 in 5 will be admitted to an intensive care unit (ICU). However, the chances that a patient will go to an ICU is highly dependent upon which hospital they are admitted to. For example, some hospitals admitted only 3% of patients with pulmonary embolism to an ICU while others admitted almost 80%.

• Importantly, the differences in how hospitals use their ICU for patients with pulmonary embolism was not entirely related to the patient’s need for life support measures, the things that the ICU is designed to deliver. For example, the ICU patients in high ICU-use hospitals tended to receive fewer procedures, including mechanical ventilation, arterial catheterization, central lines, and medications to dissolve blood clots. This suggest that high utilizing hospitals are admitting patients to the ICU with weaker indications for ICU admission.

• Medical Research: Were any of the findings unexpected?• Dr. Cooke: We know from prior research that care delivered in an ICU is often quite expensive relative

to the care provided in other areas of the hospital. We expected that hospitals that admitted more of their patients with pulmonary embolism to the ICU would also be the higher cost hospitals. However, this was not the case. In fact, we observed no differences in either the costs for other outcomes, such a patient’s risk of death or their risk for hospital readmission, in hospitals using more ICU care. This may be because hospitals that admit more patients with pulmonary embolism to the ICU are admitting those with fewer needs for ICU therapies, thereby negating some of the excess costs of care in an ICU.

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ICU Admission For Pulmonary Embolism Varies By HospitalMedicalResearch.com Interview with:Dr. Colin Cooke MD, MSc, MSAssistant Professor, Department of Internal Medicine University of MichiganCenter for Healthcare Outcomes and Policy Ann

Arbor, MI

• Medical Research: What should clinicians and patients take away from your report?• Dr. Cooke: Clinicians should recognize that in many patients with pulmonary embolism the

ICU is an appropriate location within the hospital to best care for patients. In particular, those who require life support measures as well as those who are at risk of rapid decompensation certainly benefit from ICU care. However, there are also likely a subset of low risk patients with PE who could effectively be managed in alternative locations. Doing so may free up ICU beds for more acutely ill patients, and ultimately reduce the costs of care for patients with this condition.

• Medical Research: What recommendations do you have for future research as a result of this study?

• Dr. Cooke: The most important next steps will require a better understanding of why ICU admission practice varies so dramatically across hospitals. Because we observed no differences in outcomes in pulmonary embolism patients across hospitals with differing ICU use, this suggests that there may be great opportunities to improve the efficiency in use of the ICU.

• Citation:• Hospital-level variation in intensive care unit admission and critical care procedures for patie

nts hospitalized for pulmonary embolism• Andrew J. Admon, MD, MPH; Christopher W. Seymour, MD, MSc; Hayley B. Gershengorn, MD

; Hannah Wunsch, MD, MSc; Colin R. Cooke, MD, MSc, MS• Chest. 2014. doi:10.1378/chest.14-0059Read the rest of the interview on MedicalResearch.comContent Not Intended as Specific Medical Advice

Opioid Deaths Particularly High Among Young PeopleMedicalResearch.com Interview with:Tara GomesSt Michael’s HospitalToronto, ON, Canada

• Medical Research: What are the main findings of the study?• Tara Gomes: We found that rates of opioid overdose in Ontario have increased more than 3-

fold over the past 2 decades. Furthermore, these deaths are clustered among younger Ontarians; in 2010, 1 in 8 deaths among those aged 25 to 34 years were related to opioids. This has led to considerable burden due to loss of life.

Medical Research: Were any of the findings unexpected?• Tara Gomes: Although past research suggested that the mean age at time of opioid-overdose

death was fairly low, we didn’t expect such a pronounced clustering of these deaths among those aged 25 to 44 years old. Furthermore, the substantial impact of this early loss of life was surprising. In 2010, 21,927 years of life lost were attributable to opioid-related death, which is more than that attributable to alcohol use disorders, pneumonia, or influenza.

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Opioid Deaths Particularly High Among Young PeopleMedicalResearch.com Interview with:Tara GomesSt Michael’s HospitalToronto, ON, Canada

• Medical Research: What should clinicians and patients take away from your report?• Tara Gomes: Clinicians should carefully consider when to prescribe opioids to their patients

and should avoid escalating to high dose therapy which has been shown to be associated with increased risk of opioid overdose. Furthermore, patients need to become informed about the risks of addiction and overdose when using opioids so that they can ensure that they do not accidentally misuse these drugs, which can lead to serious – and life threatening – consequences.

• Medical Research: What recommendations do you have for future research as a result of this study?

• Tara Gomes: Since 2010, several changes have occurred in the opioid landscape. There have been new policies implemented in Ontario that attempt to address the issue of opioid misuse and abuse, as well as several new products introduced (including both a tamper deterrent formulation and a generic formulation of long-acting oxycodone). Future research should explore the potential impact of these changes on the trends observed in this study.Citation:

• Gomes, T., Mamdani, M. M., Dhalla, I. A., Cornish, S., Paterson, J. M. and Juurlink, D. N. (2014), The burden of premature opioid-related mortality. Addiction. doi: 10.1111/add.12598

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Diabetes, Age and Obesity Drive Demand for EndocrinologistsMedicalResearch.com Interview with:Robert A. Vigersky, MDWalter Reed National Military Medical Center Bethesda, MD

• Medical Research: What type of patients do endocrinologists typically treat and why is the demand for their services anticipated to grow?

• Dr. Vigersky: Endocrinologists are physicians trained in managing, diagnosing, and treating disorders of the endocrine system: thyroid, parathyroid, adrenal glands, hypophyseal and hypothalamic axes, ovaries, testes, and pancreas. Their role involves controlling diabetes mellitus, menopause, hyperthyroidism and other conditions involving metabolism.

• A major factor affecting the anticipated demand for health care services is the aging population. In 2010, there were 37.5 million people age 65 or over, constituting about 12.7 percent of the total population, and by 2025 the population age 65 or over will number 62.5 million (17.9 percent of the population). Due to the greater prevalence of many of the diseases in older age groups, like osteoporosis, diabetes, obesity, and thyroid nodules, the growth in the population age 65 or over will exert a major influence on the demand for endocrine services.

• Diabetes, by itself, is a major driver of demand. The incidence of Type 2 diabetes rises dramatically with age, and with obesity. In an increasingly overweight population an estimated 22.3 million people in the U.S. are diagnosed with diabetes as of 2012, representing about 7 percent of the population. This estimate is higher than but consistent with those published by the CDC for 2010. The percentage of the population with diagnosed diabetes continues to rise, with one study projecting that as many as one in three U.S. adults could have diabetes by 2050 if current trends continue.

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Diabetes, Age and Obesity Drive Demand for EndocrinologistsMedicalResearch.com Interview with:Robert A. Vigersky, MDWalter Reed National Military Medical Center Bethesda, MD

• Medical Research: How large is the projected shortfall of adult endocrinologists?• Dr. Vigersky: Our baseline projections indicate that there is a substantial gap, about 1,484 full-time

equivalent endocrinologists between the adult endocrinology services demanded, measured in terms of the services that an adult endocrinologist can provide when working full time in patient care, and the amount that can be supplied by the current and projected numbers of clinically active adult endocrinologists, in 2015. The gap between the supply and demand of full-time equivalent endocrinologists is likely to persist through 2025, where we estimate it to fall slightly to 1,344. That is the best case scenario. If the prevalence of diabetes rises from a current rate of 7.4 percent to 12 percent by 2025, there will be a shortage of nearly 2,900 endocrinologists serving adults. Without a concerted effort to recruit more endocrinologists, the gap between the number of endocrinologists and the demand for their care will increase even further and patients will struggle to get the care they need.

• Medical Research: What factors contribute to the relative lack of endocrinologists?• Dr. Vigersky: A significant proportion of the adult endocrinologist workforce is Baby Boomers (born

between 1946 and 1964). Those physicians who are over age 60 will leave the workforce or will greatly reduce hours of clinical work, over the next decade. The next generation of endocrinologists also are working fewer hours and seeing fewer patients in an average week than their predecessors. Although the number of fellowship positions in the field is increasing, the modest growth is not sufficient to keep pace with the growing demand.

• Another factor that discourages physicians from specializing in endocrinology is compensation rates. Since much of the care they provide is not based around specific procedures, endocrinologists tend to earn less than their counterparts in specialties such as noninvasive cardiology and gastroenterology.

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Diabetes, Age and Obesity Drive Demand for EndocrinologistsMedicalResearch.com Interview with:Robert A. Vigersky, MDWalter Reed National Military Medical Center Bethesda, MD

• Medical Research:What recommendations do you have to increase the number and productivity of endocrinologists, in order to meet the current and anticipated demand for their services?

• Dr. Vigersky: The creation of additional fellowship positions would help ensure an adequate supply of endocrinologists to serve patients for years to come. The Endocrine Society’s workforce analysis found the number of new entrants to the workforce must grow at a rate of 14 percent a year to close the gap in five years.

• In addition, improved reimbursement rates that reflect the true value of endocrinologists’ care are required to encourage more physicians to choose endocrinology as a specialty. Meaningful salary increases may incentivize medical school graduates to select endocrinology as a specialty rather than the higher paying procedural-based specialties.

• Citation:• The Clinical Endocrinology Workforce: Current Status and Future Projections of Supply and De

mandVigersky RA1, Fish L, Hogan P, Stewart A, Kutler S, Ladenson PW, McDermott M, Hupart KH.J Clin Endocrinol Metab. 2014 Jun 18:jc20142257. [Epub ahead of print]

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Venous Thromboembolism Associated With Short and Long Term Increase In MortalityMedicalResearch.com Interview with: Kirstine Kobberøe Søgaard, MDDepartment of Clinical Epidemiology,Aarhus University Hospital, Denmark

• Medical Research: What are the main findings of the study?• Response: Venous thromboembolism (VTE) is mainly considered an acute illness with a high

mortality right after the event, whereas knowledge on the impact on long-term survival has been sparse. In our study, we used nationwide data on VTE since 1977, and included 128,223 patients with VTE and 640,760 individuals from the general population without a VTE diagnosis. We had complete follow-up data on individual patient level and were able to link information from other hospital admissions and thereby obtain each patient’s entire hospital history, as well as death statistics with specific cause of death. We confirmed the high mortality immediately after the thromboembolic event, but more interestingly, we found that mortality remained increased during the entire follow-up period of 30 years, with venous thromboembolism as an important cause of death among patients with deep venous thrombosis and/or pulmonary embolism.

Medical Research: Were any of the findings unexpected?• Response: During the study period, we observed no decrease in mortality in patients with deep

venous thrombosis, whereas 1-year mortality in patients with pulmonary embolism was markedly reduced over the last three decades. This reduction may reflect an improvement in the treatment of venous thromboembolism, but it is also likely that enhanced diagnostic procedures (identifying less serious embolisms) had an impact. While deep venous thrombosis and pulmonary embolism were likely to be the cause of death in the short term, this finding persisted even 11-30 years after diagnosis.

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Venous Thromboembolism Associated With Short and Long Term Increase In MortalityMedicalResearch.com Interview with: Kirstine Kobberøe Søgaard, MDDepartment of Clinical Epidemiology,Aarhus University Hospital, Denmark

• Medical Research: What should clinicians and patients take away from your report?• Response: VTE is not only an acute disease, but is also associated with an increased mortality

in the long term. Some of these deaths may be prevented if we learn more about optimizing the treatment of venous thromboembolism, as well as reducing the risk of venous thromboembolism recurrence.

• Medical Research: What recommendations do you have for future research as a result of this study?

• Response: The mechanism behind the increased long-term mortality risk in venous thromboembolism patients needs to be further investigated. We believe it is crucial to find out more about which diseases predict and/or mediate long-term mortality, and to gain more knowledge on how treatment may need to be personalized according to patient characteristics.

• Citation:• 30-Year Mortality Following Venous Thromboembolism: A Population-Based Cohort Study

Kirstine Kobberøe Søgaard,Morten Schmidt,Lars Pedersen,Erzsébet Horváth-Puhó,and Henrik Toft Sørensen

• Circulation. 2014;CIRCULATIONAHA.114.009107published online before print June 26 2014, doi:10.1161/CIRCULATIONAHA.114.009107

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Biomarker BNP Linked To Severity of Aortic StenosisMedicalResearch.com Interview with :Philippe Pibarot, DVM, PhD, FAHA, FACC, FESC, FASEChair, Canada Research Chair in Valvular Heart Diseases–

• Medical Research: What are the main findings of the study?• Dr. Pibarot: The optimal timing of aortic valve replacement (AVR) in asymptomatic patients

with severe aortic stenosis (AS) remains a matter of debates. Both the American and European guidelines recommend AVR for patients with severe AS who present with symptoms or left ventricular (LV) systolic dysfunction. However, patients with aortic stenosis are often older, less physically active and have more comorbidities, which make the assessment of AS-related symptoms challenging and unreliable. In this study by Capoulade et al, plasma levels of brain natriuretic peptide (BNP) were obtained in 157 patients with severe asymptomatic aortic stenosis and preserved LV ejection fraction at peak of exercise-stress echocardiography. Patients in the upper (>95 pg/ml) and mid (>45 pg/ml) tertiles of exercise BNP respectively had a 5- and 3- fold increase in the risk of events (i.e. AVR or death) compared to those in the lower tertile. Similar results were obtained in the subset of patients with low resting BNP.

Medical Research: What should clinicians and patients take away from your report?• Dr. Pibarot: These findings provide strong impetus for systematic measurement of BNP

during exercise test in asymptomatic patients with severe AS. Patients who display a marked increase in BNP during exercise require more frequent and closer clinical and echocardiographic follow-up and may potentially benefit from earlier intervention (i.e. aortic valve replacement)

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Biomarker BNP Linked To Severity of Aortic StenosisMedicalResearch.com Interview with :Philippe Pibarot, DVM, PhD, FAHA, FACC, FESC, FASEChair, Canada Research Chair in Valvular Heart Diseases–

• Medical Research: What recommendations do you have for future research as a result of this study?

• Dr. Pibarot: Further studies are needed to determine if the present findings obtained with semi-supine exercise test can be transposed to the setting of upright exercise test.

• Citation:• Prognostic value of plasma B-type natriuretic peptide levels after exercise in patients with sev

ere asymptomatic aortic stenosis• Romain Capoulade, Julien Magne, Raluca Dulgheru, Zeineb Hachicha, Jean G Dumesnil, Kim

O’Connor, Marie Arsenault, Sébastien Bergeron, Luc A Pierard, Patrizio Lancellotti, Philippe Pibarot

• Heart heartjnl-2014-305729Published Online First: 3 July 2014 doi:10.1136/heartjnl-2014-305729

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Do Antibiotics Improve Post-Op Course Following Cholecystectomy?MedicalResearch.com Interview with :Pr. Jean-Marc RegimbeauService de Chirurgie Digestive Oncologique et Métabolique,CHU dAmiens�

• Medical Research : What are the main findings of the study?• Answer: In our study we found that the absence of postoperative administration of amoxicillin plus clavulanic acid did not improve

the occurrence of postoperative infections in patients with mild or moderate acute calculous cholecystitis. The bile cultures were pathogen free in 60.9% of case. Moreover we show that less than 2 percent of the overall population presented a major complication defined according to the Clavien Dindo Classification (Clavien score ≥3a). After cholecystectomy the readmission rate was 6%.

Medical Research : Were any of the findings unexpected?• Answer: All of the surgical results (operative time, conversion rate…) were concordant with the literature. Nevertheless we reported

a perforation rate around 40%. This data, never reported in the articles, represents the daily practice. Moreover the patients with pathogens resistant to Amoxicillin plus clavulanic acid had similar length of stay and postoperative course.

• Medical Research : What should clinicians and patients take away from your report?• The main data taken away from our study are :• Postoperative administration of amoxicillin plus clavulanic acid after mild or moderate acute calculous cholecystitis lasting for less

than 5 days is not necessary (the treatment of this condition should include preoperative antibiotic and cholecystectomy)• Whatever the treatment course the readmission rate is around 6%.• Medical Research : What recommendations do you have for future research as a result of this study?• Answer: To improve the quality of the report some methodological aspects should be scheduled.• First the use of the placebo as a comparator (preferably a double placebo : one for the IV administration and one for the per os

administration).• Secondly to schedule an alternative for antibiotic regimen in case of amoxicillin plus clavulanic acid allergy. Finally to obtain the

reason of non inclusion as soon as the study begins.• Citation :• Regimbeau J, Fuks D, Pautrat K, et al. Effect of Postoperative Antibiotic Administration on Postoperative Infection Following Cholecys

tectomy for Acute Calculous Cholecystitis: A Randomized Clinical Trial. JAMA. 2014;312(2):145-154. doi:10.1001/jama.2014.7586.

• Views vs UniqueViews2014-06-182014-06-232014-06-282014-07-032014-07-08Read the rest of the interview on MedicalResearch.comContent Not Intended as Specific Medical Advice

Smoking Cessation: Odds Improved By Combining Chantix With Nicotine PatchesMedicalResearch.com Interview with:Coenie Koegelenberg, MBChB, MMed (Int), FCP (SA), MRCP (UK), Cert Pulm (SA), PhDAssociate Professor: Pulmonology

Stellenbosch University & Tygerberg Academic Hospital

• Medical Research: What are the main findings of the study?• Dr. Koegelenberg: The aim of this study was to evaluate the efficacy of combining varenicline and a

nicotine patch versus varenicline alone as an aid to smoking cessation in a double-blind study design in a larger group and with a longer assessment period than has been studied to date. It was found that the combination treatment was associated with a statistically significant and clinically important higher continuous abstinence rate at 12 weeks (55.4% vs. 40.9%; P=.007) and 24 weeks (49.0% vs. 32.6%; P=.004), and point prevalence abstinence rate at 6 months (65.1% vs. 46.7%; P=.002). The present study was not adequately powered to fully assess safety and tolerability endpoints, but the results suggest that adverse events were balanced across treatment arms, except for mild skin reactions that were more frequently observed in the nicotine patch group (14.4% vs. 7.8%, P=.03).

Medical Research: Were any of the findings unexpected?• Dr. Koegelenberg: Both varenicline and nicotine acts on the nicotinic cholinergic receptor, specifically

the α4β2 receptor subtype, which is believed to be the principal mediator of nicotine dependence. The additive efficacy of combining the two drugs therefore cannot be readily explained. It is possible that neither varenicline nor nicotine alone fully saturate all nicotine receptors in the brain, leaving room for the action of the other. Nicotine replacement may also bind to additional receptors involved in nicotine dependency. A further possibility is that the different pharmacokinetics of the two components provides a more favorable onset of receptor agonism. Moreover, it is possible that the introduction of varenicline one week after Nicotine replacement therapy, or tapering of varenicline might in some way have improved the effectiveness of the combination.

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Smoking Cessation: Odds Improved By Combining Chantix With Nicotine PatchesMedicalResearch.com Interview with:Coenie Koegelenberg, MBChB, MMed (Int), FCP (SA), MRCP (UK), Cert Pulm (SA), PhDAssociate Professor: Pulmonology

Stellenbosch University & Tygerberg Academic Hospital

• Dr. Koegelenberg: It was shown that in relatively healthy smokers, the odds of achieving successful smoking cessation after 12 and 24 weeks were significantly increased by using a combination of varenicline and nicotine patches compared to varenicline alone. The combination appeared to be safe, although further studies are needed to confirm this.

• Medical Research: What recommendations do you have for future research as a result of this study?

• Dr. Koegelenberg: The study population was limited to relatively healthy smokers. Future studies should include a broader range of smokers (including those with significant cardiovascular and/or respiratory diseases), other forms of nicotine replacement therapy and assessments of tolerability and cost/benefit comparisons with alternative therapies.

• Citation:• Koegelenberg CN, Noor F, Bateman ED, et al. Efficacy of Varenicline Combined With Nicotine R

eplacement Therapy vs Varenicline Alone for Smoking Cessation: A Randomized Clinical Trial. JAMA. 2014;312(2):155-161. doi:10.1001/jama.2014.7195.

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Nurse Visitation During Pregnancy and Infancy Reduced Maternal and Child MortalityMedicalResearch.com Interview with: David Olds, Ph.D.Professor of Pediatrics and DirectorPrevention Research Center for Family and Child Health

University of Colorado Department of Pediatrics Aurora, Colorado 80045

• Medical Research: What are the main findings of the study?• Dr. Olds: We’ve conducted a randomized controlled trial of a program of nurse home visiting for low-income

women with no previous live firths during pregnancy and the first two years of the child’s life, with randomization of participants beginning in 1990. In our most recent follow-up of mothers and children in Memphis, those who received nurse-visitation were less likely to have died over a 2-decade period following the child’s birth than those in the control group. Death among mothers and children in these age ranges in the US is rare and extraordinarily important for what it tells us about the health of the population studied in this trial.

• For children, the reduction in death was present for preventable causes, that is, sudden infant death syndrome, injuries, and homicide. All of the child deaths for preventable causes were in the control group, for whom the rate was 1.6%. None of the nurse-visited children died of preventable causes.

• The reductions in maternal mortality were found for two nurse-visited groups combined for this report: one received prenatal and newborn visitation and a second received visitation during pregnancy and through child age two. Overall, mothers assigned to the control group were nearly 3 times more likely to die than those assigned to the two nurse-visited conditions. The relative reduction in maternal mortality was particularly pronounced for deaths linked to maternal behaviors — suicide, drug overdose, injuries, and homicide; for these external causes of death, 1.7% of the mothers in the control group had died, compared to 0.2% of those visited by nurses.

•Medical Research: Were any of the findings unexpected?

• Dr. Olds: All of these findings were unexpected as we thought that the rates of maternal and child mortality for women and children in these age ranges would be too infrequently occurring to discern program effects.

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Nurse Visitation During Pregnancy and Infancy Reduced Maternal and Child MortalityMedicalResearch.com Interview with: David Olds, Ph.D.Professor of Pediatrics and DirectorPrevention Research Center for Family and Child Health

University of Colorado Department of Pediatrics Aurora, Colorado 80045

• Medical Research: What should clinicians and patients take away from your report?• Dr. Olds: Nurse visitation during pregnancy and the early years of the child’s life among low-

income mothers with no previous live births is a promising means of improving maternal and child health and reducing maternal and child mortality.

• Medical Research: What recommendations do you have for future research as a result of this study?

• Dr. Olds: These findings need to be replicated with other highly disadvantaged low-income families.

• Citation:• Olds DL, Kitzman H, Knudtson MD, Anson E, Smith JA, Cole R. Effect of Home Visiting by Nurse

s on Maternal and Child Mortality: Results of a 2-Decade Follow-up of a Randomized Clinical Trial. JAMA Pediatr. Published online July 07, 2014. doi:10.1001/jamapediatrics.2014.472.

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Recalled Yogurt Harbored Harmful FungusMedicalResearch.com Interview with:Soo Chan Lee, PhD Senior Research Associate,Center for Microbial Pathogenesis, Department of Molecular Genetics and Microbiology,Duke University Medical Center, Durham

, N.C. 27710

• Medical Research: What are the main findings of the study?• Dr. Soo Chan Lee: Mucor circinelloides strain isolated from recalled Chobani yogurt was found to be the most

virulent subspecies M. circinelloides forma circinelloides that is commonly associated with human infections. When mice were infected with this fungus through the tail-vein, 80% mortality was observed 5 days post infection. When mice were fed with spores, the fungus survived passage through the GI tract as many as 10 days, indicating the fungus can colonize to cause infections. Whole genome sequence analysis revealed the possibility that this fungus could produce harmful secondary metabolites that are unknown in this fungal species.

• Medical Research: Were any of the findings unexpected? • Dr. Soo Chan Lee: Mucor circinelloides is already known as one of the causal agents for mucormycosis, which is

rare but aggressive with high mortality in case of disseminated infections. So virulence of the fungus in mouse is kind of expected.

• However, one interesting finding was that the fungus survived the passage through the mouse GI tract.• Dr. Soo Chan Lee: When people think about food-borne pathogens, normally they list bacteria, viruses, and

parasites. Fungal pathogens are not considered food-borne pathogens. However, this incidence (Chobani yogurt recalled after customer complaints of discomfort and their products were contaminated by Mucor circinelloides) indicates that we need to pay more attention to fungi. Fungal pathogens can threaten our health systems as food-borne pathogens.

• The immunocompromised population is increasing as a result of HIV-AIDS infection, diabetes, and other medical conditions. Elderly populations are increasing too. Those people are especially susceptible to fungal infections. As mentioned above, specific attention needs to be given to fungi. It may be time to consider developing sound regulations about fungi in food products and factories that manufacture them.

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Recalled Yogurt Harbored Harmful FungusMedicalResearch.com Interview with:Soo Chan Lee, PhD Senior Research Associate,Center for Microbial Pathogenesis, Department of Molecular Genetics and Microbiology,Duke University Medical Center, Durham

, N.C. 27710

• Medical Research: What recommendations do you have for future research as a result of this study?

• Dr. Soo Chan Lee: It is less evident so far that this fungus really causes food-borne illness through infection or production of toxic compounds. Our study evaluated the potential risks of this fungal infection. Further study could include examination of whether this fungus can produce any secondary metabolites because its genome tells us it would be possible.

• Citation:• Analysis of a foodborne fungal pathogen outbreak: virulence and genome of a Mucor

circinelloides isolate from yogurt,” Soo Chan Lee, R. Blake Billmyre, Alicia Li, Sandra Carson, Sean M. Sykes, Eun Young Huh, Piotr Mieczkowski, Dennis C. Ko, Christina A. Cuomo, and Joseph Heitman. mBio, July 8, 2014. DOI:10.1128/mBio.01390-14

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Sleep Deprivation Can Induce Symptoms Resembling SchizophreniaMedicalResearch.com Interview with:Prof. Dr. Ulrich Ettinger Departments of PsychologyUniversity of BonnBonn, Germany

• Medical Research: What are the main findings of the study? • Prof. Ettinger: We found that 24-hour sleep deprivation induced subjective cognitive, perceptual and

emotional alterations resembling the symptoms of schizophrenia. We also observed that sleep deprivation led to a deficit in a sensorimotor filter mechanism called prepulse inhibition (PPI), similar to the disturbance seen in schizophrenia.

Medical Research: Were any of the findings unexpected?• Prof. Ettinger: The magnitude of the impairment in prepulse inhibition was quite astonishing.• Medical Research: What should clinicians and patients take away from your report? • Prof. Ettinger: We believe that our findings support the validity of sleep deprivation as an experimental

model system of schizophrenia. This means, that future antipsychotic drug development studies may build upon our findings by testing new compounds for their efficacy on PPI following sleep deprivation.”

• Medical Research: What recommendations do you have for future research as a result of this study?• Prof. Ettinger: We would like to replicate and extend these findings by combining our design with the

administration of an established, clinically effective antipsychotic. It will be intriguing to find out whether a drug with known antipsychotic effects will prevent and/or reverse the prepulse inhibition deficit that is produced by sleep deprivation.

• Citation:• Sleep deprivation disrupts prepulse inhibition and induces psychosis-like symptoms in healthy humans• Petrovsky N1, Ettinger U2, Hill A1, Frenzel L1, Meyhöfer I1, Wagner M3, Backhaus J1, Kumari V4.• J Neurosci. 2014 Jul 2;34(27):9134-40. doi: 10.1523/JNEUROSCI.0904-14.2014.

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Painful Diabetic Neuropathy Linked To Higher Nocturnal Blood PressureMedicalResearch.com Interview with: Vincenza Spallone MD PhDEndocrinology and NeurologyDepartment of Systems Medicine Tor Vergata University, Rome, Italy

• Medical Research: What are the main findings of the study?• Dr. Spallone:To investigate a possible relationship between painful diabetic polyneuropathy (PDPN) and the circadian pattern of

blood pressure (BP), we performed ambulatory blood pressure monitoring in 113 diabetic patients with PDPN, with painless diabetic polyneuropathy (DPN) and without DPN. In addition, we evaluated neuropathic pain, sleep, risk for obstructive sleep apnoea (OSA), autonomic function, and in a subgroup of patients, depressive symptoms.

• The main finding was that patients with painful diabetic polyneuropathy displayed impaired nocturnal fall in BP compared to those without neuropathy, and higher nocturnal systolic blood pressure than the other two groups. Although the day-night change (∆) in blood pressure failed to reach a significant difference between painful diabetic polyneuropathy and DPN groups, nondipping (the loss of nocturnal fall in systolic BP) was more strictly associated with painful diabetic polyneuropathy than DPN and in multivariate analysis, including comorbidities and most potential confounders, neuropathic pain was an independent determinant of ∆ BP and nocturnal systolic blood pressure.

• In summary, we showed a novel association of peripheral diabetic neuropathic pain with nondipping and higher systolic nocturnal blood pressure, which was not entirely explained through pain dependent sleep problems or other pain- or diabetes-related comorbidities, like CAN, OSA and depression.

• Medical Research: Were any of the findings unexpected?• Dr. Spallone: Pain-dependent sleep disturbances were a rather expected finding, even though previous studies lacked a comparison

between patients with painful and painless DPN. Here, we confirmed the negative impact of neuropathic pain on sleep and provided the finding of a peculiar link between diabetic peripheral neuropathic pain and sleep behaviour independently on possible influences of neuropathy and diabetes per se.

• Nondipping and reverse dipping patterns have been reported to be associated with CAN and linked to a disruption of the circadian variation in sympathovagal activity, i.e. a diminished increase in vagal activity during the night with a consequent sympathetic predominance. Nondipping has also been associated with short sleep duration in patients with diabetes and with OSAS in the general population. Thus, it was not obvious that the PDPN was related to nondipping and night-time BP independently from CAN influence and from the presence of sleep problems and high OSA risk. This finding possibly suggests that, in patients with painful diabetic polyneuropathy, nocturnal pain itself acts as a stressor by inducing a sympathetic response during the night with a consequent exacerbation of the pre-existent sympathovagal unbalance (associated with autonomic dysfunction secondary to diabetes and to chronic pain) and thus inhibiting BP fall during the night.

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Painful Diabetic Neuropathy Linked To Higher Nocturnal Blood PressureMedicalResearch.com Interview with: Vincenza Spallone MD PhDEndocrinology and NeurologyDepartment of Systems Medicine Tor Vergata University, Rome, Italy

• Medical Research: What should clinicians and patients take away from your report?• Dr. Spallone: We think that the finding of an association between painful diabetic polyneuropathy and both

nondipping and higher night-time BP could be of clinical relevance given the independent prognostic value of these two BP features for end-organ damage and cardiovascular morbidity and mortality in the general population and even more in diabetic population. The prognostic burden represented by nondipping and higher night-time BP increases the negative prognostic value already constituted by diabetic neuropathy itself and other comorbidities of chronic neuropathic pain, as sleep loss and disturbance.

• Painful diabetic polyneuropathy is common (with a prevalence of about 18%), and exerts a deep impact on sleep, mood, and quality of life. It is, however often undiagnosed and under-treated. This study indicates one more reason to pay attention to this diabetic complication and supports the view that diabetic peripheral neuropathic pain should increasingly be regarded as a condition of high cardiovascular risk. Chronic neuropathic pain in diabetic patients should be promptly recognized and properly managed to offer relief to patients and improve their cardiovascular risk profile.

• Medical Research: What recommendations do you have for future research as a result of this study?• Dr. Spallone: A logical development of this study would be to verify whether effective pain treatment can

correct the abnormal BP findings, i.e. lowering night-time BP and restoring dipping status, and to ascertain whether and to what degree the potential beneficial effect on BP of pain relief is direct or mediated through sleep or mood changes.

• Citation:• A Novel Association Between Nondipping and Painful Diabetic Polyneuropathy

Cinzia D’Amato, Roberto Morganti, Federica Di Gennaro, Carla Greco, Girolama A. Marfia, and Vincenza Spallone

Diabetes Care published ahead of print June 26, 2014, doi:10.2337/dc14-0528 1935-5548Read the rest of the interview on MedicalResearch.comContent Not Intended as Specific Medical Advice

Diabetes: Even High Risk Patients May Have Modifiable Risk FactorsMedicalResearch.com: Interview with:Interview with Professor Donald W Bowden and Dr. Amanda J CoxCenter for Diabetes Research,

Center for Genomics and Personalized Medicine ResearchDepartment of Biochemistry, Wake Forest School of Medicine, Winston-Salem, NC

• Medical Research: What are the main findings of the study?• Answer: The study examined modifiable cardiovascular disease (CVD) risk factors and risk for mortality in a subset of

individuals from the Diabetes Heart Study who were at high risk based for cardiovascular disease based on burden of subclinical CVD assessed by coronary artery calcified plaque scores greater than 1000. Even among this high risk group, known CVD risk factors were still useful in assessing ongoing risk for mortality. Use of cholesterol-lowering medication was one factor identified to be protective against mortality.

•Medical Research: Were any of the findings unexpected?

• Answer: It was assumed that risk for mortality would be consistently high among this subgroup given the individual histories (and duration) of type 2 diabetes and the presence of subclinical cardiovascular disease. However, 60% of this high-risk subset were still living after, on average, more than eight years of follow-up supports the potential for variable and modifiable risk, even in the presence of multiple existing risk factors.

• Medical Research: What should clinicians and patients take away from your report?• Answer: The findings from this study indicate that even among type 2 diabetes patients identified to be at high risk

of adverse outcome, modifiable risk factors exist that should be targeted for early and continued intervention.• Medical Research: What recommendations do you have for future research as a result of this study?• Answer: Identification of multiple modifiable risk factors supports the multifactorial nature of cardiovascular disease

and the need for concurrent risk reduction strategies. Future research should aim to further resolve the seemingly episodic events that lead to adverse outcome and which may explain the variable risk noted in this subset.

• Citation:• Contributors to Mortality in High-Risk Diabetic Patients in the Diabetes Heart Study• Diabetes Care published ahead of print July 2, 2014, doi:10.2337/dc14-0081 1935-5548

Amanda J. Cox, Fang-Chi Hsu, Barry I. Freedman, David M. Herrington, Michael H. Criqui, J. Jeffrey Carr, and Donald W. Bowden

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Treating Psychogenic Nonepileptic Seizures With Psychotherapy Workbook ApproachMedicalResearch.com Interview with: W Curt LaFrance Jr MD, MPHAssistant Professor of Psychiatry and Neurology, Alpert Medical School, Brown University

Director of Neuropsychiatry and Behavioral Neurology, Rhode Island Hospital Providence RI 02903-4923

• MedicalResearch: What are the main findings of the study?• Dr. LaFrance: Patients treated with the 12 session, 1 hour, individual psychotherapy

seizure treatment workbook had significant reductions in their seizures and improvement in their comorbid symptoms, quality of life and functioning. In contrast, treatment as usual /standard medical care (TAU/SMC) showed no improvement in seizures, comorbid symptoms or other outcomes.

• MedicalResearch: Were any of the findings unexpected?• Dr. LaFrance: Showing such a significant treatment effect size in the two psychotherapy

treated groups (with and without sertraline) with the small sample was unexpected. The robust results are an indicator of the impact of this intervention.

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Treating Psychogenic Nonepileptic Seizures With Psychotherapy Workbook ApproachMedicalResearch.com Interview with: W Curt LaFrance Jr MD, MPHAssistant Professor of Psychiatry and Neurology, Alpert Medical School, Brown University

Director of Neuropsychiatry and Behavioral Neurology, Rhode Island Hospital Providence RI 02903-4923

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. LaFrance: In our research, we have worked to demystify the challenging neuropsychiatric

population with Psychogenic Nonepileptic Seizures and to equip patients and clinicians with effective treatment for a disorder that has largely been avoided by mental health providers. The results show that treatment as usual / standard medical care is not helpful for Psychogenic Nonepileptic Seizures (PNES). That all of the outcomes for the TAU/SMC group showed no improvement underscores that what is being done now with supportive therapy and routine followup is not enough to help these patients. The seizure treatment workbook is a new, targeted treatment option for clinicians that has been used successfully for Psychogenic Nonepileptic Seizures and other conversion disorders. The workbook will be published later this year.

• MedicalResearch: What recommendations do you have for future research as a result of this study?

• Dr. LaFrance: Examining the impact of the workbook with other providers trained in delivering the intervention across the country will be important, as the treatment is being disseminated to other seizure centers. Many experts have noted that approaching the disorder from a combined neurologic and psychiatric perspective, with the collaboration of Neurological and Mental Health Institutes will be important for moving the field forward.

• Citation:• LaFrance W, Jr, Baird GL, Barry JJ, et al. Multicenter Pilot Treatment Trial for Psychogenic Nonepilep

tic Seizures: A Randomized Clinical Trial. JAMA Psychiatry. Published online July 02, 2014. doi:10.1001/jamapsychiatry.2014.817.

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Brain Imaging Of Psychedelic State Shows Resemblance To REM SleepMedicalResearch.com Interview with:Dr. Enzo Tagliazucchi:Goethe University, Germany

• MedicalResearch: What are the main findings of the study?• Dr. Tagliazucchi: The main finding of the study is the objective discovery of an “expanded

mind” and a more “unpredictable mind” after the ingestion of a psychedelic (in this case psilocybin, a compound found in “magic mushrooms”). We say that this discovery is objective since it comes from a brain imaging experiment (using magnetic resonance imaging) instead from reports of drug users, which could be unreliable or exaggerated.

• Also, comparing our results with those obtained in brain imaging experiments of REM sleep (the phase of sleep when we dream), we found a remarkable resemblance between both brain states. Thus, the psychedelic state perhaps has more to do with a “dream-like” state than with normal, resting wakefulness.

• MedicalResearch: Were any of the findings unexpected?• Dr. Tagliazucchi: In part, yes. The psychedelic state is strongly associated with visual and

auditory hallucinations and distortions (such as geometric patterns, for instance) and other sensory alterations (such as mixing of the senses or synesthesia). However, all our results point to “high-level” alterations in brain activity, this is, not alterations in the way we perceive the world around us, but deeper alterations in the way we put our thoughts together over time. Thus, psychedelics allow us not only to see or hear differently but also to “think differently”.

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Brain Imaging Of Psychedelic State Shows Resemblance To REM SleepMedicalResearch.com Interview with:Dr. Enzo Tagliazucchi:Goethe University, Germany

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Tagliazucchi: Psilocybin is currently being explored as a treatment for depression, anxiety and

other related disorders. Our results reveal a general effect of psilocybin on brain activity during rest (which is perhaps shared by other psychedelics). By understanding better the influence of psilocybin on the functional architecture of the human brain, we will be closer to revealing the specific effects involved in its role as anti-depressant.

• MedicalResearch: What recommendations do you have for future research as a result of this study?

• Dr. Tagliazucchi: It is necessary to study the human brain as a dynamic entity continuously evolving over time. Most studies to date treat the brain as a static object whose properties (such as connectivity) remain unchanged over several minutes. It is only by defining “brain states” and studying the temporal succession of states (a “train of thought”) that we can reveal some specific effects of psilocybin on the human brain. Otherwise, the effects would remain hidden.

• Citation:• Enhanced Repertoire of Brain Dynamical States During the Psychedelic Experience

Tagliazucchi, E. et al.• http://onlinelibrary.wiley.com/doi/10.1002/hbm.22562/abstract.• Tagliazucchi, E., Carhart-Harris, R., Leech, R., Nutt, D. and Chialvo, D. R. (2014), Enhanced repertoire

of brain dynamical states during the psychedelic experience. Hum. Brain Mapp.. doi: 10.1002/hbm.22562

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Diabetes: Combining Resistance with Aerobic Exercise May Be More Effective For Glucose ControlMedicalResearch.com: Interview with: Lukas Schwingshackl, MScDepartment of Nutritional SciencesUniversity of Vienna Vienna, AUSTRIA

• Medical Research: What are the main findings of the study?• Lukas Schwingshackl: The results of the present meta-analyses showed that, in patients with established

diabetes, aerobic training might be more effective in reducing glycosylated haemoglobin and fasting glucose when compared with resistance training. Combined aerobic and resistance training was more powerful in reducing glycosylated haemoglobin compared with aerobic training, and more effective in reducing glycosylated haemoglobin, fasting glucose and tricylglycerols when compared with resistance training. However, these results could not be confirmed when only low risk of bias studies were included.

•Medical Research: What should clinicians and patients take away from your report?

• Lukas Schwingshackl: Combined aerobic and resistance training can be recommended as part of a lifestyle programme in the management of type 2 diabetes wherever possible. However, the interpretation of these findings with respect to their clinical relevance is limited by the overall low to moderate quality of the studies included, the lack of information on clinically important outcomes.

• With respect to the potential side effects, 8/14 trials in the present meta-analysis reported adverse events such as hypoglycaemia, back pain, shoulder pain, musculoskeletal injury, tendonitis and other musculoskeletal discomforts following exercise, with no significant differences between the intervention groups. However, it remains possible that the number of adverse events will increase with the duration and intensity of exercise. There is evidence that supervised exercise is more effective than unsupervised training, but in practice it seems unlikely that most patients would have access to supervised exercise regimens of this intensity. It is possible that either aerobic training, resistance training or combined training may be easier to perform effectively without supervision, thus affecting the external validity of these results since only studies with supervised training were included.

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Diabetes: Combining Resistance with Aerobic Exercise May Be More Effective For Glucose ControlMedicalResearch.com: Interview with: Lukas Schwingshackl, MScDepartment of Nutritional SciencesUniversity of Vienna Vienna, AUSTRIA

• Medical Research: What recommendations do you have for future research as a result of this study?

• Lukas Schwingshackl: Further high quality with long-term exercise interventions including hard clinical endpoints (i.e. cardiovascular disease, mortality) are needed to develop definitive recommendations.

• Citation:Lukas Schwingshackl, Benjamin Missbach, Sofia Dias, Jürgen König, Georg Hoffmann. Impact of different training modalities on glycaemic control and blood lipids in patients with type 2 diabetes: a systematic review and network meta-analysis. Diabetologia, 2014; DOI: 10.1007/s00125-014-3303-z

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Traumatic Brain Injury: Maintaining Hemoglobin With Transfusions or EPO Found Not HelpfulMedicalResearch.com Interview with:Claudia Robertson, MDProfessor, Department of NeurosurgeryBaylor College of MedicineOne Baylor

Plaza Houston, Texas 77030

• Medical Research: What are the main findings of the study?• Dr. Robertson: We studied two issues related to treatment of anemia after severe traumatic

brain injury.• One issue was the optimal hemoglobin transfusion threshold for this subgroup of critically ill

patients, and the second issue was use of erythropoietin to increase hemoglobin concentration and reduce the need for transfusion. For the transfusion threshold, we found that there was no difference in long-term neurological outcome when patients were transfused at a hemoglobin concentration of less than 7 g/dl compared to those transfused at less than 10 g/dl. In addition, there was an increased risk of thromboembolic events in those transfused at less than 10 g/dl. With administration of erythropoietin, we found no improvements in neurological outcome, and no increase in hemoglobin concentration or reduction in the need for transfusion.

• Medical Research: Were any of the findings unexpected?• Dr. Robertson: It has been believed that maintaining hemoglobin concentration at least 10

g/dl is an important management practice to reduce secondary injury to the brain. This study does not support that practice.

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Traumatic Brain Injury: Maintaining Hemoglobin With Transfusions or EPO Found Not HelpfulMedicalResearch.com Interview with:Claudia Robertson, MDProfessor, Department of NeurosurgeryBaylor College of MedicineOne Baylor

Plaza Houston, Texas 77030

• Medical Research: What should clinicians and patients take away from your report?• Dr. Robertson: The major message is that patients with traumatic brain injury should be

managed the same as other critically ill patients with a restrictive transfusion practice. There is no advantage to maintaining hemoglobin concentration at a higher level, and there is some risk of transfusion related complications. There is also no support from this study for use of erythropoietin in patients with traumatic brain injury.

• Medical Research: What recommendations do you have for future research as a result of this study?

• Dr. Robertson: The findings with erythropoietin were disappointing because there have been many studies in experimental models of brain injury showing neuroprotection. It is possible that we are not able to give high enough doses of erythropoietin in patients because of potential side effects and that derivatives of erythropoietin which do not have these side effects may still be of interest for future clinical trials.

• Citation:• Robertson CS, Hannay H, Yamal J, et al. Effect of Erythropoietin and Transfusion Threshold on

Neurological Recovery After Traumatic Brain Injury: A Randomized Clinical Trial. JAMA. 2014;312(1):36-47. doi:10.1001/jama.2014.6490

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Cardiac Rehabilitation Enhanced By Smartphone AppMedicalResearch.com Interview with:Dr Mohanraj K KarunanithiResearch Team Leader | Integrated Mobile Health Systems The Australian e-Health Research Centre

Digital Productivity and Services Flagship CSIRO

• Medical Research: What are the main findings of the study?• Dr. Karunanithi:

• 33% more clients completed the innovative home-based cardiac rehabilitation (CR) delivery using smartphone and the internet (Care Assessment Platform CR program) compared with the traditional centre-based cardiac rehabilitation program.

• Care Assessment Platform-CR was as effective as tradition CR program in improving physical activity, diet intake, and lowering depression

• Care Assessment Platform -CR was also effective in reducing weight, and anxiety levels and more importantly, the overall health related quality of life.

• Medical Research: Were any of the findings unexpected?• Dr. Karunanithi: Considering the Care Assessment Platform CR program was a new mode of

healthcare delivery using recent advances in communication technologies in the market, such as smartphones and its connection to the internet, we did not expect adherence to be as high as 94%. This was quite impressive for a new way of healthcare delivery.

• Despite not providing a prescribed exercise program, like that conducted in the tradition centre-based exercise clinic cardiac rehabilitation program, the Care Assessment Platform CR program was equally effective in improving the physical activity of the participant. This improvement was mediated by the automated pedometer application integrated in the mobile phone and the biofeedback of the physical activity progress provided to the participant via the health diary mobile App.

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Cardiac Rehabilitation Enhanced By Smartphone AppMedicalResearch.com Interview with:Dr Mohanraj K KarunanithiResearch Team Leader | Integrated Mobile Health Systems The Australian e-Health Research Centre

Digital Productivity and Services Flagship CSIRO

• Medical Research: What should clinicians and patients take away from your report?• Dr. Karunanithi: For Clinicians, this publication is demonstrates that a comprehensive delivery of

cardiac rehabilitation using smartphone and the internet can deliver the same health benefits as that of the centre-based CR program. They also have the potential to individualise the cardiac program and goals according to the patient’s medical condition and needs. Furthermore, healthcare services can provide their clients (based on their suitability) the option of Care Assessment Platform as a CR delivery program who are inaccessible to cardiac rehabilitation services or those who are reluctant to undergo a centre-based CR program.

• For patients, Care assessment platform CR provides patient choice of another cardiac rehabilitation program, if they wish not to undertake a group-based centre-based program. By the provision the Care Assessment Platform CR, they will have a more individualised CR program delivered in their home setting, with similar engagement with a carer as that of the centre-based CR but by a more remote contact through their mobile phone. The Care Assessment Platform CR program would be well suited to clients who are in their working life and want to undertake their cardiac rehabilitation while they return to work.

• Medical Research: What recommendations do you have for future research as a result of this study?• Dr. Karunanithi: Due to the ability of smartphone and internet technologies to reach and deliver care remotely, Care

Assessment Platform could be used to deliver cardiac rehabilitation to the under serviced communities such as in the rural and remote regions. Because lifestyle and biomedical risk factor modifications are similar among some of the key chronic diseases, such as cardiovascular and diabetes, and because Care Assessment Platform was used to deliver these risk factor modifications, it is possible for it to be applied to secondary prevention of other disease management.

• Citation:• Smartphone-based home care model improved use of cardiac rehabilitation in postmyocardial infarction patients: re

sults from a randomised controlled trial• Marlien Varnfield, Mohanraj Karunanithi, Chi-Keung Lee, Enone Honeyman, Desre Arnold, Hang Ding, Catherine Smit

h, Darren L Walters• Heart heartjnl-2014-305783Published Online First: 27 June 2014 doi:10.1136/heartjnl-2014-305783Read the rest of the interview on MedicalResearch.comContent Not Intended as Specific Medical Advice

VA Study Defines Optimum Exercise Capacity Threshold By AgeMedicalResearch.com Interview with:Peter Kokkinos PhDVeterans Affairs Medical Center, Cardiology DivisionWashington, DC 20422

• Medical Research: What are the main findings of the study?• Dr. Kokkinos: The main finding of the study is that we defined an exercise capacity threshold for each

age category (<50; 50-59; 60-69; and ≥70 years of age). The mortality risk increases progressively below this threshold and decreases above it. We then calculated the 5 and 10-year mortality risk for each age category.

Medical Research: Were any of the findings unexpected?• Dr. Kokkinos: The unexpected findings of this study were:• 1) the strength of the impact of fitness across all age categories, including those ≥70 years;• 2) Exercise capacity 2 or more METs below the threshold (Least and Low fitness categories) had a more

pronounced unfavorable impact in younger than older individuals. However, the favorable impact of exercise capacity above the age-specific category was similar across all age categories.

• Medical Research: What should clinicians and patients take away from your report?• Dr. Kokkinos: Prior to this study, we knew that exercise capacity, estimated in METs (metabolic

equivalents) by a standardized exercise test, was inversely associated with mortality risk. That is, the lower the exercise capacity the higher the risk of premature death. However, we did not know the exercise capacity threshold beyond which risk changed. Furthermore, since exercise capacity is strongly influenced by age, this elusive threshold was likely to be different for different age categories. The aim of the study was to define the exercise capacity threshold for each age category and then quantify the risk associated below and above this threshold. Health care professionals can now use this threshold to quantify the 5 and 10-year mortality risk for each patient undergoing an exercise tolerance test.

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VA Study Defines Optimum Exercise Capacity Threshold By AgeMedicalResearch.com Interview with:Peter Kokkinos PhDVeterans Affairs Medical Center, Cardiology DivisionWashington, DC 20422

• Medical Research: What recommendations do you have for future research as a result of this study?

• Dr. Kokkinos: The cohort of the current study consisted of 18,102 male veterans. Future studies should be conducted for females and perhaps for individuals with different chronic conditions such as hypertension, type 2 diabetes mellitus and obesity.

• Citation:• Age-Specific Exercise Capacity Threshold for Mortality Risk Assessment in Male Veterans• Peter Kokkinos, Charles Faselis, Jonathan Myers, Xuemei Sui, Jiajia Zhang, and Steven N. Blair• Circulation. 2014;CIRCULATIONAHA.114.009666published online before print June 17 2014, do

i:10.1161/CIRCULATIONAHA.114.009666

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Study Links Hyperlipidemia with Breast Cancer RiskMedicalResearch.com Interview with:Dr. Rahul PotluriHonorary Clinical Lecturer in Cardiology School of Medical Sciences, Aston UniversityBirmingham UK;

• Medical Research: What are the main findings of the study?• Dr. Potluri: Study was conducted by a retrospective analysis of more than 1 million

anonymous patient records across the UK between 2000 and 2013 using the Algorithm for Comorbidities, Associations, Length of stay and Mortality (ACALM) protocol.

• There were 664,159 women and of these, 22 938 had hyperlipidaemia and 9 312 had breast cancer. Some 530 women with hyperlipidaemia developed breast cancer. A statistical model to study the association between hyperlipidaemia and breast cancer. They found that having hyperlipidaemia increased the risk of breast cancer by 1.64 times (95% confidence interval 1.50-1.79).

Medical Research: Were any of the findings unexpected?• Dr. Potluri: No. A recent paper published in Science magazine suggested a link for high

cholesterol and breast cancer in mice and various other studies have suggested a link between obesity and breast cancer. In this context, which these results are interesting, they are not unexpected.

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Study Links Hyperlipidemia with Breast Cancer RiskMedicalResearch.com Interview with:Dr. Rahul PotluriHonorary Clinical Lecturer in Cardiology School of Medical Sciences, Aston UniversityBirmingham UK;

• Medical Research: What should clinicians and patients take away from your report?• Dr. Potluri: This is a very preliminary study and further research is required before anything

can be confirmed. However, 10-15 years down the line, if further prospective studies confirm these findings, there is the the possibility for the trial of interventions to lower cholesterol in the management of breast cancer. These include lifestyle modifications and medications such as statins. However, at this time point, the advise would be the same as it is currently, lead an active lifestyle, exercise and ensure cholesterol is well controlled.

• Medical Research: What recommendations do you have for future research as a result of this study?

• Dr. Potluri: A prospective study that monitors the risk of breast cancer in women with and without high cholesterol is needed to confirm what we observed. If the connection between high cholesterol and breast cancer is validated, the next step would be to see if lowering cholesterol with interventions such as lifestyle modifications or statins can reduce the risk of developing cancer.

• Citation: Abstract presented at the:Frontiers in CardioVascular Biology 2014 abstract discussing:Association found between high cholesterol and breast cancer

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Value of H-FABP as Potential Biomarker of Pulmonary EmbolismMedicalResearch.com Interview with: Dr. Liang HeDepartment of AnesthesiologyYan’an Hospital of Kunming City, kunming, 650051, China

• MedicalResearch: What are the main findings of this study?• Dr. He: We evaluated the prognostic value of plasma heart-type fatty acid binding protein (H-

FABP) in patients with acute pulmonary embolism (PE) with the guidelines of acute PE of European Society Cardiology (ESC).

• We found that higher H-FABP level (above 6 or 7 ng/ml) was associated with an increased of 30-d mortality and complicated clinical events, from six studies of 85 articles included. H-FABP has the potential to be a novel prognostic marker that can help optimize patient management strategies and risk-stratification algorithms in the population of patients with acute pulmonary embolism. However, few studies had been specifically designed to answer our research questions.

• Our pooled estimates of prognostic performance are not adjusted for confounding factors such as age, sex, hemodynamic, methodologies, or history of heart function. Therefore, sound prospective cohort, multi-center and large sample studies with definitions of acute PE under international guidelines are required to further increase confidence in the value of H-FABP.

• Citation:• Prognostic value of plasma heart-type fatty acid binding protein in patients with acute pulmon

ary embolism: a meta-analysis

Published online July 03, 2014. doi:10.1378/chest.13-1008Read the rest of the interview on MedicalResearch.comContent Not Intended as Specific Medical Advice

Much of HIV Transmission Driven By Herpes Co-InfectionMedicalResearch Interview with: Dr. Don C. Des Jarlais PhDDirector, International Research Core, Center for Drug Use and HIV Research Research Fellow, NDRI

Director of Research, Baron Edmond de Rothschild Chemical Dependency Institute, Beth Israel Medical CenterProfessor of Epidemiology, Department of Epidemiology and Population Health, Albert Einstein College of Medicine

• Medical Research: What are the main findings of the study?• Dr. Des Jarlais: HIV infection among non-injecting users of heroin and cocaine doubled

doubled over the last several decades, from 7% to 14%. Herpes simplex virus type 2 (HSV-2) increases both susceptibility to and transmissibility of HIV. We examined HSV-2 infection among non-injecting heroin and cocaine user over the same time period using stored serum samples. HSV-2 infection was strongly related to HIV infection, and both increased over time. We calculated population attributable risk percentages (PAR%) to estimate the extent to which HSV-2 was driving increased HIV infection. HSV-2 infection was responsible for approximately half of the increase in HIV infection

Medical Research: Were any of the findings unexpected?• Dr. Des Jarlais: It is well known that HSV-2 infection increases HIV transmission, but it was

surprising to see this large an effect. This is similar to what has happened with HSV-2 and HIV in sub-Saharan Africa.

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Much of HIV Transmission Driven By Herpes Co-InfectionMedicalResearch Interview with: Dr. Don C. Des Jarlais PhDDirector, International Research Core, Center for Drug Use and HIV Research Research Fellow, NDRI

Director of Research, Baron Edmond de Rothschild Chemical Dependency Institute, Beth Israel Medical CenterProfessor of Epidemiology, Department of Epidemiology and Population Health, Albert Einstein College of Medicine

• Medical Research: What should clinicians and patients take away from your report?• Dr. Des Jarlais: It is critical that persons infected with both HIV and HSV-2 should go on anti-

retroviral treatment and use condoms so that they do not transmit HIV to others.Persons who are infected with HSV-2 and engaging in behavior that puts them at high risk for acquiring HIV should use condoms consistently and also consider pre-exposure prophylaxis (PrEP) to avoid becoming infected with HIV.

• Medical Research: What recommendations do you have for future research as a result of this study?

• Dr. Des Jarlais: If we are going to have an “AIDS free generation” in the US, we will need to focus additional prevention efforts on persons with HSV-2 infection. How to reach these persons and best enroll them in treatment and prevention services are urgent research questions. This applies to men-who-have sex with men also.

• Citation:• HSV-2 Co-Infection as a Driver of HIV Transmission among Heterosexual Non-Injecting Drug U

sers in New York City• Don C. Des Jarlais, Kamyar Arasteh, Courtney McKnight, David C. Perlman, Jonathan Feelemye

r, Holly Hagan, Hannah L. F. Cooper• Published: January 31, 2014 DOI: 10.1371/journal.pone.0087993

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Heart Failure: Low Prealbumin At Discharge Linked to MortalityMedicalResearch.com Interview with: Dr. Patrícia LourençoServiço de Medicina Interna, Centro Hospitalar São JoãoFaculdade de Medicina da Universidade do Porto,Unidade

I&D Cardiovascular do Porto Monteiro, Portugal;

• Medical Research: What are the main findings of the study?• Dr. Lourenço: A low prealbumin at hospital discharge associates with morbidity and mortality in acute heart failure patients.

The prognostic value of low prealbumin in heart failure is independent of other nutritional markers and of the inflammatory status.

•Medical Research: Were any of the findings unexpected?

• Dr. Lourenço: Prealbumin is an established marker of nutritional status and is a negative acute phase protein. Despite we cannot consider the results completely unexpected, the fact that prealbumin had an association with prognosis beyond the effect of the nutritional and inflammatory media suggests an intrinsic prognostic role for prealbumin in heart failure. The possibility that prealbumin has some detoxifying capacity is kept open apart from theorically possible.

• Medical Research: What should clinicians and patients take away from your report?• Dr. Lourenço: Heart Failure can course with undernutrition in a multifactorial process. Heart Failure is a low grade

inflammatory condition. The prealbumin value of an acute heart failure patient reflects nutrition and inflammation and it can be looked at as a marker of morbidity and mortality.

• Medical Research: What recommendations do you have for future research as a result of this study?• Dr. Lourenço: Probably the two main yet unanswered questions are:• 1) What are the main pathophysiologycal mechanisms underlying the transition between normal weight to weight loss and

cachexia establishment in heart failure patients ?;• 2) Is there a place for therapeutic options intended to halt and/or reverse undernutrition in heart failure ? Further research

should address these issues.• Citation:• Low prealbumin is strongly associated with adverse outcome in heart failure• Patrícia Lourenço, Sérgio Silva, Fernando Friões, Margarida Alvelos, Marta Amorim, Marta Couto, Paulo Torres-Ramalho, João

Tiago Guimarães, José Paulo Araújo, Paulo Bettencourt• Heart heartjnl-2014-305747Published Online First: 1 July 2014 doi:10.1136/heartjnl-2014-305747

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Validating Medicare Claims Data For StrokeMedicalResearch.com Interview with Hiraku Kumamar, MD, MPH Department of EpidemiologyHarvard School of Public Health, Boston, MA andSoko Setoguchi-Iwata, M.D. Duke Clinical Research

Institute Durham, NC 27715

• Medical Research: What are the main findings of the study?• Answer: We evaluated the accuracy of discharge diagnosis of stroke in the Medicare claims

database by linking it to a nationwide epidemiological study cohort with 30239 participants called REasons for Geographic And Racial Differences in Stroke (REGARDS). We found that among the 282 events captured using a strict claims definition of stroke, 91% were true events. We also found that 12% of the overall strokes had been identified only by Medicare claims, strongly supporting the use of these readily available data for event follow-up in cohort studies.

• Medical Research: Were any of the findings unexpected?• Answer: As more and more researches are being conducted using Medicare claims data, it

was important to up-date the accuracy of stroke diagnosis as diagnostic modalities and coding practices change over time. The study was innovative in that it was conducted by linking the Medicare claims to national cohort of general subjects living in the community, not to patients with particular diseases like many of the previous studies.

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Validating Medicare Claims Data For StrokeMedicalResearch.com Interview with Hiraku Kumamar, MD, MPH Department of EpidemiologyHarvard School of Public Health, Boston, MA andSoko Setoguchi-Iwata, M.D. Duke Clinical Research

Institute Durham, NC 27715

• Medical Research: What should clinicians and patients take away from your report?• Answer: Clinicians should know that when searching and critically appraising evidence from

observational studies using stroke outcome captured by Medicare inpatient data, the results from studies comparing two or more therapies will be valid due to the high specificity of Medicare stroke diagnosis. However, studies that report incidence and prevalence rates of strokes using Medicare inpatient data will not be as reliable due to low sensitivity of inpatient Medicare diagnosis of stroke.

• Medical Research: What recommendations do you have for future research as a result of this study?

• Answer: More research is needed to explore the methods that maximize the accuracy of diagnoses recorded in these administrative databases which is especially useful for studies that looks for real-world evidence in the effectiveness and safety of medical products. For stroke, future researches should try to identify definitions that preserve similar specificity to our definition but capture more cases (more sensitive), so that we can use them to accurately capture the frequencies of strokes in the Medicare population.

• Citation :Validity of Claims-Based Stroke Algorithms in Contemporary Medicare Data: Reasons for Geographic and Racial Differences in Stroke (REGARDS) Study Linked With Medicare Claims

Hiraku Kumamaru, Suzanne E. Judd, Jeffrey R. Curtis,Rekha Ramachandran, N. Chantelle Hardy, J. David Rhodes, Monika M. Safford, Brett M. Kissela, George Howard, Jessica J. Jalbert, Thomas G. Brott, and Soko Setoguchi

• Circ Cardiovasc Qual Outcomes. 2014;CIRCOUTCOMES.113.000743published online before print June 24 2014, doi:10.1161/CIRCOUTCOMES.113.000743

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Poor Sleep Plagues Socioeconomically Deprived NeighborhoodsMedicalResearch.com Interview with: Nathaniel F. Watson, MD, MScProfessor of Neurology, University of Washington

Co-director, University of Washington Medicine Sleep CenterDirector, Harborview Medical Center Sleep Clinic Seattle, Washington

• MedicalResearch: What are the main findings of the study?

Dr. Watson: The Singh Index is a composite measure of socioeconomically deprived neighborhoods. We found that as Singh Index increased, sleep duration reduced. This was true in the total sample of twins, and within twin pairs. The fact that we saw this within twin pairs means the association is present after controlling for genetics and shared environment, which substantially strengthens the association.

•MedicalResearch: Were any of the findings unexpected?

Dr. Watson: We also found a gene by environment interaction. As Singh Index went up, the total genetic and non-shared environmental variability of sleep duration also went up. So the more socioeconomically deprived the neighborhood, the more erratic the sleep duration, both shorter and longer then the healthy 7-9 hours per night that we recommend.

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Poor Sleep Plagues Socioeconomically Deprived NeighborhoodsMedicalResearch.com Interview with: Nathaniel F. Watson, MD, MScProfessor of Neurology, University of Washington

Co-director, University of Washington Medicine Sleep CenterDirector, Harborview Medical Center Sleep Clinic Seattle, Washington

• MedicalResearch: What should clinicians and patients take away from your report?

Dr. Watson: These results are a starting point for discussing the impact that neighborhood level factors have on sleep duration. If we improve upon social deprivation, we may have an opportunity to improve upon sleep habits that influence how long people sleep.

• MedicalResearch: What recommendations do you have for future research as a result of this study?

• Dr. Watson: We need to assess more specific individual measures of the impact of built environment, such as noise and pollution sensors and activity monitors, to more specifically assess the particular aspects of neighborhood deprivation that impact sleep length.

• Citation:• Watson NF, Horn E, Buchwald D, Turkheimer E, Vitiello MV, Pack AI, Duncan GE. Sleep duratio

n and social deprivation in twins. Sleep. 2014; 37 Suppl: 0212.

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Newer Drug-Eluting Stents Narrow Gap Between Cardiac Bypass and Stent Surgery OutcomesMedicalResearch.com Interview with: Sripal Bangalore, MD, MHADirector of Research, Cardiac Catheterization Laboratory, Director

, Cardiovascular Outcomes Group,Associate Professor of Medicine, New York University School of Medicine, New York, NY 10016

• edical Research: What are the main findings of the study?• Dr. Bangalore: We found that while CABG was associated with mortality benefit when compared with

bare metal stents or first generation drug eluting stent, the gap between CABG and PCI was smaller and non significant when PCI was with newer generation DES. The same was true for repeat revascularization with the magnitude of benefit with CABG descending considerable from comparison with balloon angioplasty to newer generation DES.

Medical Research: Were any of the findings unexpected?• Dr. Bangalore: I wouldn’t call it unexpected but many of us had wondered about this question and it is

good to see some hypothesis generating data.• Medical Research: What should clinicians and patients take away from your report?• Dr. Bangalore: We need clinical trials to prove our hypothesis. Up until that time, if a diabetic has

disease treatable by either PCI or CABG the discussion w the patient should be about upfront risk of stroke with CABG vs late small increase of repeat revascularization with PCI.

• Medical Research: What recommendations do you have for future research as a result of this study?• Dr. Bangalore: The question about CABG or PCI with newer generation DES should be tested in future

trials. That is the only way of testing the hypothesis we have generated.• Citation:• Outcomes With Coronary Artery Bypass Graft Surgery Versus Percutaneous Coronary Intervention for Pa

tients With Diabetes Mellitus: Can Newer Generation Drug-Eluting Stents Bridge the Gap?Circ Cardiovasc Interv.2014;CIRCINTERVENTIONS.114.001346published online before print June 17 2014, doi:10.1161/CIRCINTERVENTIONS.114.001346Read the rest of the interview on MedicalResearch.comContent Not Intended as Specific Medical Advice

Nasal Cavity Malignancies: Charged Particle Therapy May Be Superior To Conventional Photon TherapyMedicalResearch.com Interview with:Dr. Robert Foote MDChair, Department of Radiation OncologyMayo Clinic, Rochester, MN

• MedicalResearch: What are the main findings of the study?• Dr. Foote: Charged particle therapy (mainly protons and carbon ions) provide superior overall

survival, disease-free survival and tumor control when compared to conventional photon therapy. In particular, it appears that proton beam therapy provides superior disease-free survival and tumor control when compared to the state of the art intensity modulated radiation therapy using photons.

•MedicalResearch: Were any of the findings unexpected?

• Dr. Foote: Our hypothesis was that charged particle therapy would result in better tumor control and survival due to the ability to give a higher dose of radiation by taking advantage of the superior physical characteristics and dose distribution and perhaps increased radiobiologic effectiveness. The evidence seems to support this hypothesis. The risk for neurologic toxicity seemed to be higher with the use of charged particles. This was somewhat unexpected because of the superior dose distribution achievable with charged particle therapy. However, this may have been offset by using a higher dose of radiation therapy with charged particle therapy and perhaps scattered beam technology. Unfortunately, there was inadequate information available related to radiation dose and dose distribution to evaluate this.

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Nasal Cavity Malignancies: Charged Particle Therapy May Be Superior To Conventional Photon TherapyMedicalResearch.com Interview with:Dr. Robert Foote MDChair, Department of Radiation OncologyMayo Clinic, Rochester, MN

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Foote: Patients with a variety of malignancies arising in the nasal cavity and/or paranasal sinuses who

have indications for preoperative, postoperative or primary radiation therapy should be preferentially treated with charged particle therapy, including proton beam therapy, if at all possible. Survival and tumor control appear to be improved with the use of charged particle therapy.

• MedicalResearch: What recommendations do you have for future research as a result of this study?• Dr. Foote: These types of malignancies in this location are relatively rare so it will be difficult to successfully

complete a randomized controlled clinical trial comparing charged particles to photons. Therefore, we would recommend that all institutions with charged particle therapy and/or intensity modulated radiation therapy enroll their patients on multi-institutional prospective registries or phase I/II clinical trials using standardized treatment protocols and collecting provider and patient reported outcomes using validated instruments to provide prospectively collected outcomes data for tumor control, survival, and acute and late toxicity. Cost data should also be collected prospectively in order to perform cost effectiveness analyses. Now that intensity modulated proton beam therapy is becoming more widely available, comparisons in outcomes should be made between scattered beam and intensity modulated proton beam therapy technology particularly with regard to neurologic toxicity.

• Citation:• Charged particle therapy versus photon therapy for paranasal sinus and nasal cavity malignant diseases: a sys

tematic review and meta-analysis• Dr Samir H Patel MD,Zhen Wang PhD,William W Wong MD,Mohammad Hassan Murad MD,Courtney R Bucke

y PhD,Khaled Mohammed MBBCh,Fares Alahdab MD,Osama Altayar MD,Mohammed Nabhan MD,Steven E Schild MD,Robert L Foote MD

The Lancet Oncology – 27 June 2014 DOI: 10.1016/S1470-2045(14)70268-2Read the rest of the interview on MedicalResearch.comContent Not Intended as Specific Medical Advice

Pediatric Celiac Disease: Using HLA Genotype To Help Determine RiskMedicalResearch.com Interview with: Dr. Daniel Agardh M.D., Ph.DDepartment of Pediatrics Diabetes and Celiac Disease UnitSkåne University Hospital Malmo, Sweden,

• MedicalResearch: What are the main findings of the study?• Dr. Agardh: In this study, we stratify the risk of celiac disease among children according to their HLA genotype and

country of residence. We confirm that HLA-DQ2/2 genotype is the major risk factor for early celiac disease, but also show how the risk differs between the participating countries despite of sharing similar HLA risk. This points to the direction of an interaction between HLA and the environment that eventually lead to an autoimmune response in genetic susceptible children.

MedicalResearch: Were any of the findings unexpected?• Dr. Agardh: The increased risk among the Swedish participants is intriguing and needs to be further explored.• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Agardh: Celiac disease may develop at an early age and is not always clinically evident in young children. This

study demonstrates how clinicians who follow celiac patients may use HLA to estimate the risk among first-degree relatives.

• MedicalResearch: What recommendations do you have for future research as a result of this study?• Dr. Agardh: Our study highlights the importance of identifying both genetic and non-genetic factors that lead to

celiac diease autoimmunity in some but not all children. As TEDDY is a longitudinal prospective study that follows children from birth to 15 years of age at six clinical centers in four different countries using the same study protocol, we have a unique opportunity to identify which factors that are responsible for developing type 1 diabetes, celiac diease, or both disorders. For celiac disease, we will in future studies particular focus on how the diet will affect the micobiota, or vice versa, that might lead to an autoimmune response in the gut.

• Citation:• Risk of Pediatric Celiac Disease According to HLA Haplotype and Country• Edwin Liu, M.D., Hye-Seung Lee, Ph.D., Carin A. Aronsson, M.Sc., William A. Hagopian, M.D., Ph.D., Sibylle Koletzko, M

.D., Ph.D., Marian J. Rewers, M.D., M.P.H., George S. Eisenbarth, M.D., Ph.D., Polly J. Bingley, M.D., Ezio Bonifacio, Ph.D., Ville Simell, M.Sc., and Daniel Agardh, M.D., Ph.D. for the TEDDY Study Group

• N Engl J Med 2014; 371:42-49July 3, 2014 DOI: 10.1056/NEJMoa1313977Read the rest of the interview on MedicalResearch.comContent Not Intended as Specific Medical Advice

PAD: Polyphenols in Dark Chocolate May Improve Peripheral Artery DiseaseMedicalResearch.com Interview with:Lorenzo Loffredo, MD and Francesco Violi, MDDepartment of Internal Medicine and Medical SpecialtiesSapienza

University of Rome, Rome, Italy;

• MedicalResearch: What are the main findings of the study?• Answer: Dark chocolate is rich of polyphenols; these natural substances exert antioxidant

properties and, through an increase of nitric oxide, dilate arteries. Our research group applied this effect to enhance blood flow in a very common disease, the peripheral arterial disease. This disease is characterized by reduced blood flow to the limbs. There are not any drugs that improve this blood flow, but dark chocolate could.

• Our study suggest that dark chocolate, and only dark chocolate, could reduce oxidative stress and improve blood flow and walking autonomy in patients with peripheral arterial disease. We observed no effect on blood flow, oxidative stress and on walking autonomy in PAD patients after milk chocolate assumption. This lack of effect was probably due to the low concentration of polyphenols in milk chocolate.

•MedicalResearch: Were any of the findings unexpected?

• Answer: No, because previous studies demonstrated that dark chocolate produce beneficial effects 2 hours after ingestion. The maintenance of the effect requires further studies.

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PAD: Polyphenols in Dark Chocolate May Improve Peripheral Artery DiseaseMedicalResearch.com Interview with:Lorenzo Loffredo, MD and Francesco Violi, MDDepartment of Internal Medicine and Medical SpecialtiesSapienza

University of Rome, Rome, Italy;

• MedicalResearch: What should clinicians and patients take away from your report?• Answer: After eating the dark chocolate, PAD patients walked an average 11 percent farther and 15 percent

longer. Oxidative stress, arterial dilation and walking autonomy were assessed 2 hours after eating dark chocolate.

• We gave 40 grams of dark chocolate (about 200 calories); it is necessary to control the total daily amount of calories. Only after future studies with chronic assumption of dark chocolate we’ll have information about cardiovascular diseases and walking autonomy in this setting.

• MedicalResearch: What recommendations do you have for future research as a result of this study?

Answer: This is a pilot study. If the results of our studies will be confirmed by future studies with chronic ingestion of polyphenols, it would open novel therapeutic strategies in this setting using a natural substance.

• However, chronic assumption in follow-up is necessary to evaluate if the beneficial effect in terms of walking autonomy and reduction of oxidative stress is still effective.

• Citation:• Dark Chocolate Acutely Improves Walking Autonomy in Patients With

Peripheral Artery Disease• Lorenzo Loffredo, MD; Ludovica Perri, MD; Elisa Catasca, MD; Pasquale Pignatelli, MD; Monica Brancorsini,

NP; Cristina Nocella, PhD;Elena De Falco, PhD; Simona Bartimoccia, PhD; Giacomo Frati, MD; Roberto Carnevale, PhD; Francesco Violi, MD

• DOI: 10.1161/JAHA.114.001072 Journal of the American Heart Association

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Accidents and Violence Account For Most Deaths Among US Young PeopleMedicalResearch.com Interview with:Tamara Haegerich, PhDDeputy Associate Director for ScienceDivision of Unintentional Injury Prevention

CDC – National Center for Injury Prevention and Control

• MedicalResearch: What are the main findings of the study?• Dr. Haegerich: In the first three decades of life, more people in the US die from injuries and

violence than from any other cause. Approximately 60% of fatal injuries are unintentional (for example, from motor vehicle crashes, drug overdose, and falls), 20% are due to suicide, and 20% are due to homicide. Injuries and violence have been linked to a wide range of physical, mental health, and reproductive health problems, and chronic diseases. They take an enormous economic toll, including the cost of medical care and lost productivity. Importantly, injuries and violence are preventable through education, behavior change, policy, engineering, and environmental supports. For example, laws that promote the use of seat belts and child safety seats, and prevent drunk driving, can reduce motor-vehicle-related injuries. Early childhood home visitation, school-based programs, and therapeutic foster care are examples of evidence-based approaches to preventing violence. Improving proper prescribing of painkillers and access to treatment for substance misuse could prevent prescription drug overdoses. Improvements are possible by framing injuries and violence as preventable, identifying interventions that are cost-effective and based on research, providing information to decision makers, and strengthening the capacity of the health care system.

• MedicalResearch: Were any of the findings unexpected?• Dr. Haegerich: The findings are concerning. Nearly 180,000 people in the US die every year from

injuries and violence related to preventable events such as car crashes, drug overdoses, falls, assaults, drowning, and self-harm. This means that there is one injury death approximately every three minutes.

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Accidents and Violence Account For Most Deaths Among US Young PeopleMedicalResearch.com Interview with:Tamara Haegerich, PhDDeputy Associate Director for ScienceDivision of Unintentional Injury Prevention

CDC – National Center for Injury Prevention and Control

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Haegerich: In clinical settings, injury prevention is not integrated fully in practice. Patients are not as

familiar with ways to prevent injuries as they are with those for other major killers such as heart disease. Health providers can implement screening and referral for injury risk factors, such as depression, domestic violence, alcohol misuse, and behavioral problems in children. Health systems can integrate clinical decision support for injury prevention within electronic health records so that clinicians can easily follow guidelines and assessment protocols. Patients can talk to their physicians about their risk for injuries and violence – for example, if they are having problems with depression, substance use, or within their personal relationships.

• MedicalResearch: What recommendations do you have for future research as a result of this study? • Dr. Haegerich: Researchers can develop the science to better understand the burden, effective prevention

strategies, and how to get research translated into practice. Better tracking and monitoring is needed to allow more timely and accurate data. Interventions need to be rigorously tested to determine their health effects and return on investment for the health system. We require a better understanding of how to get practitioners to use evidence-based strategies and implement them as they are intended. Overall, research can inform how to change environments to make safe choices the easier choices.

• Citation:• Prevention of injury and violence in the USA• Tamara M Haegerich, Linda L Dahlberg, Thomas R Simon, Grant T Baldwin, David A Sleet, Arlene I Greenspa

n, Linda C Degutis• www.thelancet.com• Published online July 2, 2014 http://dx.doi.org/10.1016/S0140-6736(14)60074-X

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Sickle Cell Disease Potentially Cured with Nonmyeloablative HLA-Matched Allogeneic Stem Cell TransplantationMedicalResearch.com Interview with: Dr. John Tisdale MDMolecular and Clinical Hematology Branch

National Institute of Diabetes and Digestive and Kidney Diseases,National Heart, Lung, and Blood Institute, Bethesda, Maryland

• MedicalResearch: What are the main findings of the study?• Dr. Tisdale: Using a nonmyeloablative allogeneic HLA-match peripheral blood stem cell

transplantation strategy aimed at tolerance induction, we were able to revert the phenotype in 26 of 30 adult patients with severe sickle cell disease ranging in age from 16 to 65 years. In contrast to standard transplantation strategies which rely on high doses of chemo and/or radiotherapy after which the entire bone marrow and blood system is replaced by that of the donor, our patients had a mixture of their own and that of their donor. This procedure was well tolerated, with no non-relapse mortality, and led to complete replacement of red blood cells by that of the donor in successfully engrafted patients. This replacement resulted in decreases in pain, pain medication usage, hospitalizations, and improvements in organ function.

•MedicalResearch: Were any of the findings unexpected?

• Dr. Tisdale: There were two unexpected, but welcome findings in the study.• The first was the absence of graft-versus-host disease, a very common complication of bone

marrow transplantation in which the immune cells of the donor attack the skin and organs of the patient. This complication can be severe, even fatal, but was not observed in any of our patients.

• The second unexpected finding was that despite our patients having a mixture of both donor and patient cells in the bone marrow and blood termed mixed chimerism, we were able to successfully stop immunosuppression medication in more than half of the successfully engrafted patients with continued stable mixed chimerism.

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Sickle Cell Disease Potentially Cured with Nonmyeloablative HLA-Matched Allogeneic Stem Cell TransplantationMedicalResearch.com Interview with: Dr. John Tisdale MDMolecular and Clinical Hematology Branch

National Institute of Diabetes and Digestive and Kidney Diseases,National Heart, Lung, and Blood Institute, Bethesda, Maryland

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Tisdale: Clinicians should consider nonmyeloablative allogeneic HLA-matched peripheral

blood stem cell transplantation in adults with severe sickle cell disease and should incorporate a discussion of this potentially curative option into their care.

• MedicalResearch: What recommendations do you have for future research as a result of this study?

• Dr. Tisdale: Future research in this area should include extension of this potentially curative approach to half-matched family members, and such studies are currently underway.

• Citation:• Nonmyeloablative HLA-Matched Sibling Allogeneic Hematopoietic Stem Cell Transplantation f

or Severe Sickle Cell Phenotype• Hsieh MM, Fitzhugh CD, Weitzel R, et al. Nonmyeloablative HLA-Matched Sibling Allogeneic H

ematopoietic Stem Cell Transplantation for Severe Sickle Cell Phenotype. JAMA. 2014;312(1):48-56. doi:10.1001/jama.2014.7192.

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Systemic Sclerosis: Autologous Hematopoietic Stem Cell Transplantation vs IV Pulse CyclophosphamideMedicalResearch.com Interview with:Prof. Dr. Jacob M. van LaarProfessor and ChairDept of Rheumatology & Clinical Immunology

University Medical Center Utrecht

• MedicalResearch: What are the main findings of the study?• Prof. van Laar: The results of the ASTIS-trial demonstrate that stem cell transplantation in selected patients

with early, diffuse cutaneous systemic sclerosis, a rare, autoimmune connective tissue disease, prolongs long-term survival and improves clinical manifestations (skin, lung) and quality of life, when compared to monthly infusions with cyclophosphamide. The benefits must be weighed against the risks which include early treatment-related mortality (10% in the ASTIS-trial) and viral infections.

• MedicalResearch: Were any of the findings unexpected?• Prof. van Laar: The beneficial effect of stem cell transplantation on survival was particularly evident in non-

smoking patients. Also, stem cell transplantation resulted in a modest decline in kidney function which appeared transient. These unexpected findings merit further study.MedicalResearch: What should clinicians and patients take away from your report?

• Prof. van Laar: Stem cell transplantation may be considered a treatment option for a subgroup of systemic sclerosis patients with recent disease onset and clinical features of severe disease or rapidly progressive diseases with poor prognosis.

• MedicalResearch: What recommendations do you have for future research as a result of this study?• Prof. van Laar: Further studies are needed to determine how to optimize patient selection and modification

of the protocol to reduce the acute toxicity of the conditioning regimen without losing efficacy. In addition, further analysis of clinical and laboratory parameters of the ASTIS trial data may help identify factors which earlier predict non-responsiveness in the control arm.

• Citation:• van Laar JM, Farge D, Sont JK, et al. Autologous Hematopoietic Stem Cell Transplantation vs Intravenous Puls

e Cyclophosphamide in Diffuse Cutaneous Systemic Sclerosis: A Randomized Clinical Trial. JAMA. 2014;311(24):2490-2498. doi:10.1001/jama.2014.6368.

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Poor Sleep Linked To Faster Brain AgingMedicalResearch.com: Interview with:Dr. June Chi-Yan Lo Research FellowCognitive Neuroscience LaboratoryDuke-NUS Graduate Medical School Singapore

• edicalResearch: What are the main findings of the study?• Dr. Lo: The Duke-NUS study examined the data of 66 older Chinese adults, from the

Singapore-Longitudinal Aging Brain Study. Participants underwentstructural MRI brain scans measuring brain volume and neuropsychologicalassessments testing cognitive function every two years. Additionally,their sleep duration was recorded through a questionnaire. Those who sleptfewer hours showed evidence of faster brain aging and decline in cognitiveperformance.

MedicalResearch: Were any of the findings unexpected?• Dr. Lo: Not really. Past research has examined the impact of sleep duration on

cognitive functions in older adults. We added to the literature by showingthat in addition to age-related cognitive changes, brain aging is alsoelevated by short sleep.

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Lo: Our findings showed that one way to slow structural brain changes

associated with aging is to have sufficient sleep.• MedicalResearch: What recommendations do you have for future research as a result of this study?• Dr. Lo: It is still not clear whether sleeping for long duration will have

negative impact on brain aging. In fact, long sleep has been associatedwith higher risk for cardiovascular diseases and various forms of cancer.Citation:Sleep Duration and Age-Related Changes in Brain Structure and Cognitive Performance

• June C. Lo, PhD; Kep Kee Loh, MSc; Hui Zheng, MEng; Sam K.Y. Sim, BSc; Michael W.L. Chee, MBBS• Journal Sleep VOLUME 37, ISSUE 07

http://dx.doi.org/10.5665/sleep.3832

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Insulin Pump May Be A Valuable Option For Difficult Type 2 DiabetesMedicalResearch.com Interview with:Professor Yves ReznikDepartment of Endocrinology,University of Caen Côte de Nacre Regional Hospital Center Caen, France

• MedicalResearch: What are the main findings of the study?• Prof. Reznik: OPT2MISE definitively demonstrate that pump therapy is a valuable option for

treating those type 2 diabetes patients with uncontrolled hyperglycemia despite a high dose insulin regimen including at least 3 injections per day of rapid-acting and slow-acting insulin analogues, the gold standard for intensified insulin therapy. Such benefit on glucose control is obtained with lower daily insulin doses and without weight gain in comparison with multiple injection therapy. Pump therapy is effective in a population of patients un-preselected for their ability to deal with a medical device.

• MedicalResearch: Were any of the findings unexpected?• Prof. Reznik: We were very impressed by the lack of incidence of severe hypoglycemia in the

cohort of patients using pump therapy during the 6-month period of the study, and by the very low incidence of severe hyperglycemia since only 2 patients out of 168 experienced an episode of hyperglycemia or ketosis but without ketoacidosis. These results emphasize the safety of pump therapy in this population.

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Insulin Pump May Be A Valuable Option For Difficult Type 2 DiabetesMedicalResearch.com Interview with:Professor Yves ReznikDepartment of Endocrinology,University of Caen Côte de Nacre Regional Hospital Center Caen, France

• MedicalResearch: What should clinicians and patients take away from your report?• Prof. Reznik: In this difficult population of patients with severe insulin resistance and poor glucose

control, complex multiple injection regimens have several limitations such as the burden of dose tracking and scheduling or insulin injection omissions. In this perspective, pump therapy is a valuable therapeutic option.

• Furthermore, the finding that patients with mild cognitive impairment did experience the same benefits as the general population suggests that pump treatment can be used effectively by almost all patients, even older ones.

• MedicalResearch: What recommendations do you have for future research as a result of this study?• Prof. Reznik: Whereas it’s now proven that currently available insulin pump are effective, those

findings still have to be confirmed by future research for more simple and basic T2 designed pumps.• Future studies may also be conducted with use of new concentrated insulin compounds which may

enhance pump efficacy.• Citation:• Insulin pump treatment compared with multiple daily injections for treatment of type 2 diabetes (Op

T2mise): a randomised open-label controlled trial

Dr Yves Reznik MD,Ohad Cohen MD,Ronnie Aronson MD FRCPC FACE,Ignacio Conget MD,Sarah Runzis MSc,Javier Castaneda MSc,Scott W Lee MD,for the OpT2mise Study Group

The Lancet – 3 July 2014 DOI: 10.1016/S0140-6736(14)61037-0

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Is Testosterone Protective Against Heart Attack in Older Men?Med calResearch.com Interview with: Jacques Baillargeon, PhDDirector, Epidemiology Division Associate ProfessorDepartment of Preventive Medicine and Community Health

University of Texas Medical Branch

• MedicalResearch: What are the main findings of the study?• Dr. Baillargeon: The main findings of the study were that older men who were treated with

testosterone did not appear to have an increased risk of Myocardial Infarction. For men with high MI risk, testosterone use appeared to be modestly protective against MI.

•MedicalResearch: Were any of the findings unexpected?

• Dr. Baillargeon: The study was motivated by the growing concern, based on recent studies, that testosterone therapy may increase men’s risk for cardiovascular disease, specifically heart attack. We were interested in examining this research question in a large representative sample of older adult Medicare beneficiaries.

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Is Testosterone Protective Against Heart Attack in Older Men?Med calResearch.com Interview with: Jacques Baillargeon, PhDDirector, Epidemiology Division Associate ProfessorDepartment of Preventive Medicine and Community Health

University of Texas Medical Branch

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Baillargeon: This was a methodologically rigorous study of a large nationally

representative cohort of “real-world” older males. We believe it should thoughtfully weighed and considered in the debate on the issue of testosterone and cardiovascular risks.

• MedicalResearch: What recommendations do you have for future research as a result of this study?

• Dr. Baillargeon: It will be important for researchers to continue to conduct large-scale clinical trials with sufficient statistical power and follow-up time to examine adverse events in men receiving testosterone. Given the increased number of middle aged men receiving testosterone prescriptions (ref: Baillargeon et al, JAMA Internal Medicine, 2013), it will also be important to examine risks and benefits in these younger age groups.

• Citation:• Jacques Baillargeon et al. Risk of Myocardial Infarction in Older Men Receiving Testosterone

Therapy. Annals of Pharmacotherapy., July 2014 DOI: 10.1177/1060028014539918

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Changes in Gut Bacteria May Influence Diabetes and ObesityMedicalResearch.com Interview with:Yalcin Basaran, MDGulhane Military Medical Academy School of MedicineAnkara, Turkey.

• MedicalResearch: What are the main findings of the study?• Dr. Basaran: We designed a cross-sectional study to identify the relation between the gut microbiota composition

and obesity and diabetes. 27 severely obese individuals (20 men and 7 women with mean BMI: 39.98±5.56 kg/m2), 26 patients with newly diagnosed type 2 diabetes (18 men and 8 women with mean BMI: 28.63±5.08 kg/m2) and 28 healthy control subjects (22 men and 6 women with mean BMI: 23.02±1.70 kg/m2), between 18-65 years of age, were included in the present study. None of the participants was undergoing chronic treatment and no antibiotics, probiotics or prebiotics were taken within 3 months before collecting fecal material. Fecal samples were self-collected in sterile boxes, stored at -80o until analysis, and analyzed by quantitative real-time PCR for the presence of the most common types of intestinal bacteria.

• Although tended to increase, we observed no significant difference between the three groups in regards to fecal concentrations of Bacteroidetes. There was also no considerable difference in the fecal Bifidobacteria, Firmicutes and Clostridium Leptum levels among the obesity and diabetes groups. However, Bifidobacteria, Firmicutes and Clostridium Leptum counts were all significantly lower in obese and diabetic patients compared with healthy control individuals. Additionally, logistic regression analysis showed that parameters of adiposity (weight, BMI and waist circumference) and those of glucose control (FBG and HbA1c) were related to the altered gut microbiota composition. This suggests that alterations in the gut microbiota composition may influence metabolic profile in humans.

• MedicalResearch: Were any of the findings unexpected?• Dr. Basaran: Studies in humans investigating the association between specific bacterial species and obesity and

diabetes reported conflicting results. Some described a positive correlation, some demonstrated an inverse relationship, and others did not find any correlation between intestinal bacterial counts and obesity and diabetes. Thus, we tried to clarify the possible association between our microbial partners and these disorders.

• However, further studies should be carried out to elucidate whether the gut microbial changes are a cause or effect of metabolic diseases.

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Changes in Gut Bacteria May Influence Diabetes and ObesityMedicalResearch.com Interview with:Yalcin Basaran, MDGulhane Military Medical Academy School of MedicineAnkara, Turkey.

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Basaran: Obesity and diabetes are of the greatest public health challenges of the 21st century

and the numbers of those affected continue to rise at an alarming rate. In addition to lifestyle changes (dietary habits and reduced physical activity level) and the genetic susceptibility, changes in the gut microbial composition may also be responsible for that increase. This ‘novel’ partner, named as gut microbiota, consists of at least 10 fold more cells than those in the human body and is predicted to affect the body weight and glucose metabolism.

• MedicalResearch: What recommendations do you have for future research as a result of this study?

• Dr. Basaran: The manipulation of the intestinal microbiota using probiotics, prebiotics or fecal transplantation may help prevent or even treat diseases such as obesity and type 2 diabetes.

• Especially, fecal transplantation is an exciting area of research. Further prospective clinical investigations of fecal microbiota transplantation in patients with obesity and diabetes are needed to confirm this hypothesis.

• Citation:• Abstract presented at International Society of Endocrinology and the Endocrine Society: ICE/ENDO

2014 in Chicago• Gulhane Military Medical Academy School of Medicine

Department of EndocrinologyPapers:

• LB-PP02-1 Comparison of Gut Microbiota in Obese, Diabetic and Healthy Control IndividualsRead the rest of the interview on MedicalResearch.comContent Not Intended as Specific Medical Advice

Improving Breast Cancer Diagnosis With Non-Invasive PET/MRIMedicalResearch.com Interview with:Dr. Katja Pinker MDDepartment of RadiologyMedical University of Vienna ·

• MedicalResearch.com: What are the main findings of the study?

Dr. Pinker: We hypothesized that by imaging multiple key processes involved in cancer development and growth with multiparametric PET/MRI an improved non-invasive diagnosis of breast tumors is possible. To test this hypothesis, we conducted this first clinical feasibility study.

• Mutliparametric PET/MRI allows an improved non-invasive differentiation of benign and mailgnant breast tumors than currently used contrast-enhanced MRI alone. By its use unnecessary breast biopsies in benign tumors can be avoided without missing cancer.

• MedicalResearch.com: Were any of the findings unexpected?• Dr. Pinker:: We were not surprised by the results. Our previous studies as well as studies from other authors

have shown that the more information we can get about breast tumors, the deeper is the understanding of tumor biology, the more accurate is tumor characterization and the better is the diagnosis.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Pinker:: Currently new radiotracers specifically targeting key processes involved in cancer growth as well

as other MRI parameters are under investigation and translated into the clinics. This first clinical feasibility study has to be seen as a frame-work for further PET/MRI studies using specific radio tracers or other novel MR parameters.

• Citation:• Improved Differentiation of Benign and Malignant Breast Tumors with Multiparametric 18

Fluorodeoxyglucose Positron Emission Tomography Magnetic Resonance Imaging: A Feasibility Study• Katja Pinker, Wolfgang Bogner, Pascal Baltzer, Georgios Karanikas, Heinrich Magometschnigg, Peter Brader, S

tephan Gruber, Hubert Bickel, Peter Dubsky, Zsuzsanna Bago-Horvath, Rupert Bartsch, Michael Weber, Siegfried Trattnig, and Thomas H. Helbich

• Clin Cancer Res July 1, 2014 20:3540-3549; Published OnlineFirst June 30, 2014; doi:10.1158/1078-0432.CCR-13-2810

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St. John’s Wort May Cause Dangerous Drug InteractionsMedicalResearch.com Interview with: Scott A. Davis, MAResearch Administrative CoordinatorDepartment of DermatologyWake Forest School of Medicine

• MedicalResearch: What are the main findings of the study?• Answer: St. John’s wort (SJW), a common complementary and alternative medicine (CAM)

treatment for depression, is frequently used together with drugs that may interact dangerously with it. In data from the 1993-2010 National Ambulatory Medical Care Survey, a nationally representative survey of physician visits from the National Center for Health Statistics, SJW was prescribed together with drugs such as selective serotonin reuptake inhibitors (SSRIs), benzodiazepines, warfarin, statins, digoxin, verapamil, and oral contraceptives. Using SJW together with other antidepressants may cause serotonin syndrome, a potentially fatal condition.

MedicalResearch: Were any of the findings unexpected?• Answer: Yes, in 28% of St. John’s wort visits, we observed prescription of drugs that may have

a dangerous interaction. This is a disturbingly high rate of co-prescribing these combinations of drugs, exposing patients to considerable risk of serious consequences they are probably not aware of.

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St. John’s Wort May Cause Dangerous Drug InteractionsMedicalResearch.com Interview with: Scott A. Davis, MAResearch Administrative CoordinatorDepartment of DermatologyWake Forest School of Medicine

• MedicalResearch: What should clinicians and patients take away from your report?• Answer: Clinicians should be aware that St. John’s wort is a very common, popular treatment

that many patients like to use, but it also has significant interactions with many drugs. They should not assume that because it is “all natural”, it is necessarily completely safe. Many patients are on multiple other drugs and may have unexpected reactions, such as failure of their antihypertensive treatments or contraceptives, when St. John’s wort is added.

• Patients should be very careful to inform their doctor fully of all medications and supplements they are taking, such as SJW, and should be sure they know all potential risks of drug interactions before starting a new medication.

• MedicalResearch: What recommendations do you have for future research as a result of this study?

• Answer: Future research should define more precisely the risks associated with drug interactions involving St. John’s wort, especially interactions with other antidepressants. Research should also seek to inform physicians and patients more fully about how to avoid unsafe interactions when using complementary and alternative medicine treatments like St. John’s wort.

• Citation:• Use of St. John’s Wort in Potentially Dangerous Combinations

DavisScott A., FeldmanSteven R., and TaylorSarah L.. The Journal of Alternative and Complementary Medicine. -Not available-, ahead of print. doi:10.1089/acm.2013.0216.

• Views vs UniqueViews2014-06-182014-06-232014-06-282014-07-032014-07-08

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Links Between Breast Cancer and Obesity StudiedMedicalResearch.com Interview with Sai-Ching Jim Yeung, MD, PhD, FACP Professor of MedicineThe University of Texas MD Anderson Cancer CenterDepartment of Emergency Medicine

Department of Endocrine Neoplasia & Hormonal Disorders Houston, Texas 77230-1402

• MedicalResearch: What are the main findings of the study?• Dr. Yeung: We believe that this study has bridged a significant gap in knowledge between epidemiological data (the association of obesity and poor breast cancer prognosis) and

biological mechanisms mediating the impact of obesity on cancer. This study provides an important mechanistic insight into the causal relationship between obesity and breast cancer growth.

• Direct evidence for the links between obesity-associated changes in the biological processes and hallmarks of cancer in human estrogen receptor-positive (ER+) breast cancer. • It is well known that obesity is associated epidemiologicaly with decreased survival in ER+ breast cancer patients. Although a body of experimental literature exists to suggest

important roles for estrogen, insulin/IGF-1 and adipokine signaling and inflammation in the mechanisms mediating the impact of obesity on cancer, direct evidence for these mechanisms and their importance relative to one another is lacking in cancers from obese humans.

• Functional transcriptomic analysis of a prospective observation cohort with treatment-naïve ER+ breast cancer samples identified the insulin/PI3K signaling and secretion of cytokines among the top biological processes involved. Many of the obesity-associated changes in biological processes can be linked to cancer hallmarks. Upstream regulator analysis identified estrogen (?-estradiol), insulin (INS1), insulin-like growth factor-1 (IGF1), and adipokines [vascular endothelial growth factor A (VEGFA), tissue necrosis factor (TNF), interleukin-6 (IL6), oncostatin-M (OSM), chemokine ligand 5 (CCL5), leptin (LEP), leukemia inhibitory factor (LIF), C-reactive protein (CRP), adiponectin (ADIPOQ), and interleukin-10 (IL10)] in mediating the impact of obesity on human ER+ breast cancer.

• Experimental evidence that obesity causes accelerated oncogene-driven ER+ breast cancer carcinogenesis.• While it is not possible to conduct a human experiment to prospectively examine the causal relationship between obesity and breast cancer, we created a transgenic mouse

model with genetically induced obesity and oncogene-driven breast cancer. With this model we found strong in vivo evidence using both longitudinal experiments and cross-sectional experiments that obesity accelerated oncogene-driven breast carcinogenesis.

• Our mouse model phenocopied obese ER+ breast cancer patients and recapitulated transcriptomic changes associated with obesity in humans.• The human obesity phenotype is characterized by over consumption of food, insulin resistance, and increased estrogen level. The Ay/a genotype causes obesity in mice. These

mice are obese without having to change the composition and fat content of the chow. Both the obese mice and the control lean mice were fed with the same chow, eliminating the influence of dietary composition on carcinogenesis. This obesity model has intact leptin signaling as opposed to other models such as those with ob/ob mutation or db/db mutation. This mouse model also recapitulated the human obesity endocrinology profile (high estrogen, fasting insulin and IGF-1 levels). The MMTV-TGF? transgene is causing the breast cancer formation. Therefore, the Ay/a model phenocopied many characteristics of human obesity.

• Functional transcriptomic analysis similar to our analysis of the human breast cancer samples was performed on breast cancers from obese and lean control mice. Comparison of mouse data with human data showed that, although there were differences in specific mediators or the relative contribution by specific mediators involved, the major features of the obesity-induced functional changes of the transcriptomic landscape in human breast cancers were recapitulated in the mouse breast cancers. The similarity between the data from human and mouse breast cancers supports the extension of findings in our mouse model (i.e., obesity accelerated oncogene-driven breast carcinogenesis, and cancer growth of already transformed breast epithelial cells) to humans.

• Mature adipocytes stimulated breast cancer cell proliferation at least in part humorally obesity accelerated ER+ breast cancer growth after malignant transformation had already occurred.

• An in vitro co-culture model revealed that adipocyte-secreted adipokines (e.g., TIMP-1) regulate adipocyte-induced breast cancer cell proliferation and invasion. Metformin suppress adipocytes-induced cell proliferation and adipocytes-secreted adipokines in vitro. We also investigate whether obesity can accelerate breast cancer cell proliferation, tumor formation and progression using an obese orthotopic-allograft model. This mouse model promoted cancer progression.

• Major role of the Akt/mTOR pathway in obesity-induced breast carcinogenesis and tumor progression. Metformin and everolimus can suppress obesity-induced adipokines secretion and breast tumor formation and growth.

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Links Between Breast Cancer and Obesity StudiedMedicalResearch.com Interview with Sai-Ching Jim Yeung, MD, PhD, FACP Professor of MedicineThe University of Texas MD Anderson Cancer CenterDepartment of Emergency Medicine

Department of Endocrine Neoplasia & Hormonal Disorders Houston, Texas 77230-1402

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Yeung: Adipokine secretion and Akt/mTOR activation play important roles in obesity-accelerated

breast cancer aggressiveness in addition to hyperinsulinemia, estrogen signaling, and inflammation. Metformin and everolimus have potential for therapeutic interventions of ER+ breast cancer patients with obesity.

• Weight loss presumably should slow down ER+ breast cancer progression in overweight and obese patients.

• MedicalResearch: What recommendations do you have for future research as a result of this study?• Dr. Yeung: Postmenopausal patients with metastatic ER+ breast cancer may be treated with

exemestane and everolimus. Overweight and obese patients often develop hyperglycemia with everolimus. Metformin may improve hyperglycemia by improving insulin resistance. The combination of everolimus and metformin may be beneficial for overweight and obese patients with advanced ER+ breast cancer. Future research should include a prospective clinical trial to evaluate the efficacy of metformin and everolimus in overweight and obese ER+ breast cancer patients.

• Citation:• Effects of Obesity on Transcriptomic Changes and Cancer Hallmarks in Estrogen Receptor–Positive Br

east Cancer

Enrique Fuentes-Mattei, Guermarie Velazquez-Torres, Liem Phan, Fanmao Zhang, Ping-Chieh Chou, Ji-Hyun Shin, Hyun Ho Choi, Jiun-Sheng Chen, Ruiying Zhao, Jian Chen, Chris Gully, Colin Carlock, Yuan Qi, Ya Zhang, Yun Wu, Francisco J. Esteva, Yongde Luo, Wallace L. McKeehan, Joe Ensor, Gabriel N. Hortobagyi, Lajos Pusztai, W. Fraser Symmans, Mong-Hong Lee, and Sai-Ching Jim Yeung

JNCI J Natl Cancer Inst (2014)106 (7):dju158 doi:10.1093/jnci/dju158Read the rest of the interview on MedicalResearch.comContent Not Intended as Specific Medical Advice

Asymptomatic Atrial Fibrillation Relatively Common In Cryptogenic StrokeMedicalResearch.com Interview with:Dr. Tommaso Sanna MDInstitute of CardiologyCatholic University of the Sacred Heart Rome, Italy

• MedicalResearch: What are the main findings of the study?• Dr. Sanna: In patients with cryptogenic stroke, continuous ECG monitoring with an implantable device,

called the Reveal XT Insertable Cardiac Monitor (ICM), discovered Atrial Fibrillation in 6.4 times more patients than conventional diagnostic strategies at six months, 7.3 times more patients at 12 months, and 8.8 times more patients at 36 months. In more detail, after 36 months of follow-up, 30% of patients with cryptogenic stroke had at least one episode of atrial fibrillation.

MedicalResearch: Were any of the findings unexpected?• Dr. Sanna: Nearly 80% of the episodes were asymptomatic and therefore impossible to detect with

symptom-based diagnostic strategies.• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Sanna: The detection of atrial fibrillation in patients with previous ischemic stroke is a strong risk factor

for stroke recurrence, and should prompt clinicians to prescribe anticoagulant treatment.• MedicalResearch: What recommendations do you have for future research as a result of this study?• Dr. Sanna: Future research should be addressed to identify patients who benefit most from long term

monitoring and to better understand the relation between Atrial Fibrillation detection, Atrial Fibrillation duration and stroke recurrence.

• Citation:• Cryptogenic Stroke and Underlying Atrial Fibrillation

Tommaso Sanna, M.D., Hans-Christoph Diener, M.D., Ph.D., Rod S. Passman, M.D., M.S.C.E., Vincenzo Di Lazzaro, M.D., Richard A. Bernstein, M.D., Ph.D., Carlos A. Morillo, M.D., Marilyn Mollman Rymer, M.D., Vincent Thijs, M.D., Ph.D., Tyson Rogers, M.S., Frank Beckers, Ph.D., Kate Lindborg, Ph.D., and Johannes Brachmann, M.D. for the CRYSTAL AF Investigators

• N Engl J Med 2014; 370:2478-2486June 26, 2014DOI: 10.1056/NEJMoa1313600Read the rest of the interview on MedicalResearch.comContent Not Intended as Specific Medical Advice

Aspirin and Lifestyle Changes May Modulate Colon Cancer RiskMedicalResearch.com Interview with:Kaspar Truninger, MD, FMHGastroenterology and Internal MedicineLangenthal, Switzerland

• MedicalResearch: What are the main findings of the study?• Dr. Truninger: In our study, we investigated the effect of lifestyle exposure on DNA

methylation. We measured genome-wide promoter CpG methylation in 1092 normal colon biopsies from 546 healthy females. We observed that fewer CpGs acquired age-dependent methylation in users of aspirin and hormonal replacement therapy compared with nonusers, whereas more CpGs were affected in smokers and individuals with a body mass index > 25 compared with nonsmokers and less obese females. Half of the CpGs showing age-dependent methylation gain were hypermethylated in tissue of colorectal cancer. These loci gained methylation with a higher rate and were particularly susceptible to lifestyle exposure compared to age-only methylated CpGs. In addition, these CpGs were enriched for polycomb regions. Finally, all effects were different according to the anatomic location along the colon.

• MedicalResearch: Were any of the findings unexpected?• Dr. Truninger: We were surprised by both the highly significant enrichment for polycomb

regions and the higher median methylation change rate in CpGs being hypermethylated in colorectal cancer and showing age-dependent methylation gain in normal tissue as compared to sites displaying age-dependent methylation increase in normal tissue, but not hypermethylated in tumor tissue. Promoter CpG methylation (in)stability is not a universe phenomenon, but is modulated in a locus specific manner by both biological and lifestyle factors.

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Aspirin and Lifestyle Changes May Modulate Colon Cancer RiskMedicalResearch.com Interview with:Kaspar Truninger, MD, FMHGastroenterology and Internal MedicineLangenthal, Switzerland

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Truninger: Lifestyle factors that are well know modulaters of colorectal cancer risk have

widespread effects on stability of gene promoter methylation in the aging colonic mucosa. These findings provide an important resource to understand the interplay between lifestyle exposure and aging of the colonic mucosa in the evolution of cancer methylomes. Our data suggest that regular aspirin use stabilizes DNA methylation at promoters of genes controlling critical cancer pathways.

• MedicalResearch: What recommendations do you have for future research as a result of this study?

• Dr. Truninger: Future studies have to further establish the interaction between lifestyle exposure and cancer-relevant promoter methylation changes to develop tailored preventive strategies, i.e., which individuals might have a benefit from cancer preventive aspirin use.

• Citation:• Modulation of Age- and Cancer-Associated DNA Methylation Change in the Healthy Colon by

Aspirin and Lifestyle

Faiza Noreen, Martin Röösli, Pawel Gaj, Jakub Pietrzak, Stefan Weis, Patric Urfer, Jaroslaw Regula, Primo Schär, and Kaspar Truninger

• JNCI J Natl Cancer Inst (2014) 106 (7): dju161 doi:10.1093/jnci/dju161

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Women May Be More Comfortable Seeking Mental Health Support Than MenMedicalResearch.com Interview with: Dr. Flora I Matheson PhDCentre for Research on Inner City HealthSt. Michael’s Hospital Toronto, ON, Canada

• MedicalResearch: What are the main findings of the study?• Dr. Matheson: • We found that women were 10 per cent more likely to use mental health services than men.• And that within any 3-year period, women with physical illness used medical services for

mental health treatment 6 months earlier than men.•

MedicalResearch: Were any of the findings unexpected?• Dr. Matheson: The finding that women with physical illness sought care earlier than men

with physical illness was unexpected and one not previously reported.

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Women May Be More Comfortable Seeking Mental Health Support Than MenMedicalResearch.com Interview with: Dr. Flora I Matheson PhDCentre for Research on Inner City HealthSt. Michael’s Hospital Toronto, ON, Canada

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Matheson: The findings could point to something positive – that women are more comfortable seeking mental

health support than men.• Or the findings may reflect that symptoms are women for worse among women so that women to seek help sooner.• Or they might mean that men defer seeking treatment for mental health concerns.• So, we still have much to learn about the relationship between physical illness and onset of use of medical services

for mental illness.• MedicalResearch: What recommendations do you have for future research as a result of this study?• Dr. Matheson: I think the findings suggest that there is an opportunity to provide more comprehensive care for

patients with physical health problems. For example, a physician, social worker, or nurse who is aware that patients with a physical health condition will often later seek care for mental health concerns could be proactive and within routine appointments, check in with patients on their mental health state. Given that men are less likely to seek care for mental health concerns in general touching base with male and female patients is equally important.

• The lead author is currently exploring the complex relationship between problem gambling, mental illness, drug/alcohol abuse and homelessness. This is a qualitative study designed to understand how problem gambling is linked to homelessness among men who are experiencing or have experienced mental illness and drug/alcohol abuse. She is also exploring issues of brain injury among people who enter the prison system in Canada to understand whether brain injury is a risk factor for incarceration, and if it affects the ability of those with a previous brain injury to adapt to the prison environment.

• Citation:Physical health and gender as risk factors for usage of services for mental illness

• Flora I Matheson, Katherine L W Smith, Ghazal S Fazli, Rahim Moineddin, James R Dunn, Richard H Glazier• J Epidemiol Community Health jech-2014-203844Published Online First: 25 June 2014 doi:10.1136/jech-2014-203844

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Small Changes Improve Geographic Disparity in Kidney TransplantationMedicalResearch.com Interview with Daniela P Ladner, MD, MPH, FACSAssistant Professor Transplant SurgeryDepartment of Surgery, Division of Organ Transplantation

Feinberg School of Medicine, Northwestern Universit

• MedicalResearch: What are the main findings of the study?• Dr. Ladner: With the current kidney organ allocation system, there exists significant geographic disparity between the 58 Donor

Services Areas (DSAs) in the US, which are distributed among 11 regions. This means that depending on where a patient lives it might take shorter or longer to receive a kidney organ for transplantation. Despite efforts, this has not improved over the course of 20 years and in most regions this has worsened. In 1991 and 1992 respectively, two states changed their kidney allocation system, such that kidneys would first be allocated with the DSA of procurement, then statewide, then regionally (which may include several states) and then nationally. Usually kidneys don’t get allocated statewide before regionally.

• The main finding of this study is that in those two states (FL, TN), where a minor change to the kidney allocation was put into place, there was significant reduction in the geographic disparity between their Donor Services Areas. In other comparable states (equal numbers of DSAs within the state) the geographic disparity did not improve and in many the geographic disparity worsened.

• MedicalResearch: Were any of these findings unexpected?• Dr. Ladner: This is an observational study. Basically a natural experiment occurred within those two states and it tremendously

impacted the geographic disparity. This was a surprising finding.• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Ladner: The findings are important, because they demonstrate a real-life scenario of improved geographic disparity in kidney

organ allocation. Presently, increased scrutiny has led to discussions about improvement of geographic disparity in kidney allocation within UNOS (United Network for Organ Sharing). As multiple models are being considered including sweeping changes to the existing allocation system, this natural history study can provide important information for this discussion, such as the potent effect of small changes to the existent allocation system. Especially, unintended consequences are already accounted for in such an experiment.

• MedicalResearch: What recommendations do you have for future research as a result of this study?• Dr. Ladner: Many models to improve geographic disparity in kidney allocation have to be examined. This study should add to the

discussion and the consideration of small changes to the existing model.• Citation:• The Effect of the Statewide Sharing Variance on Geographic Disparity in Kidney Transplantation in the United States

CJASN CJN.05350513; published ahead of print June 26, 2014, doi:10.2215/CJN.05350513Ashley E. Davis, Sanjay Mehrotra, Vikram Kilambi, Joseph Kang, Lisa McElroy, Brittany Lapin, Jane Holl, Michael Abecassis, John J. Friedewald, and Daniela P. Ladner

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Slowdown In US Health Care Costs Largely Due to Flat Physician Reimbursement, Use of Generic DrugsMedicalResearch.com Interview with: M Luca LorenzoniOECD Organisation for Economic Co-operation and Development

Health Accounts, Asian Health and Social Policy Outreach ELS/Health Division

• MedicalResearch: What are the main findings of the study?Answer:

• The United States is an outlier in the scenery of OECD as it ranks first for health care expenditure, but last for coverage.• The slowdown in US health care spending during the past decade brought the growth rate closer to that of other high-spending countries

-Canada, France, Germany, the Netherlands and Switzerland- at around 1%. Previously in 2002, the US’s health expenditure growth was around 7%, much higher than the approximate 3% which was the average for the other countries examined in the study

• Higher health-sector prices (e.g., hospital care and prescription drugs) are thought to be the main driver of expenditure differences between the US and other high-spending countries, and recent price dynamics largely explain declines in health expenditure growth.

• MedicalResearch: What should clinicians and patients take away from your report?• Answer: The higher health spending reported in the US is not simply a result of the country’s greater wealth or the age structure of its

population. Even the large prevalence of risk factors – including obesity- explains only a small part of the reported differences. Overall, the quality of the care provided does not seem to explain the higher health expenditure in the US. High health sector prices mean that patients in the United States are not receiving as much health care as the exceptional levels of expenditure would seem to suggest.

• Given that the gains which have been made in reducing health care spending are largely attributable to price dynamics (such as reduced or no growth in physician reimbursement rates, and high use of cheaper generic drugs), future economic recovery might reverse the progress that has been made in recent years in the US.

• MedicalResearch: What recommendations do you have for future research as a result of this study?• Answer: More evidence is needed to better understand the complex causal pathways that link health spending and use with health

outcomes. This could avoid possible detrimental effects on population health from tightened controls on health-care expenditure.• Citation:

Dramatic slowdown in growth of US health expenditure over last decade closes gap between USA and other high-spending countries• The Lancet, Early Online Publication, 1 July 2014

Luca Lorenzoni MSc, Annalisa Belloni MSca, Franco Sassi PhDdoi:10.1016/S0140-6736(14)60571-7

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